MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D-1282-07-S

Device Problems Break (1069); Disconnection (1171); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a patient underwent an atrial tachycardia left (l-at) procedure with a pentaray navigational eco catheter.During the mapping phase, it was noticed that the catheter splines were damaged.It was reported that the splines of the catheter were somewhat physically disconnected.However, some wires kept part of the spline connected.There was also no visualization and the electrodes were noisy.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.The biosense webster failure analysis received the catheter for analysis.The returned catheter condition parallels the damage depicted, and includes additional damage such as sharp ring edges being exposed.The reported damage was assessed as mdr reportable as the risk to the patient was critical due to the potential of thrombus from exposure of internal catheter components, or risk of complete separation of the tip or tip component.Also, the discovery of sharp rings by the biosense webster failure analysis lab reflects that the catheter integrity is not maintained and there is potential harm to the patient.Therefore, this issue has also been assessed as mdr reportable.

Manufacturer Narrative

Additional information was received on the event.There was no resistance felt while introducing or retracting the catheter from the sheath.The sheath information was not known.The insertion tool was used during the procedure.The patient did not have a prosthetic heart valve.Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial tachycardia left (l-at) procedure with a pentaray navigational eco catheter.During the mapping phase, it was noticed that the catheter splines were damaged.It was reported that the splines of the catheter were somewhat physically disconnected.However, some wires kept part of the spline connected.There was also no visualization and the electrodes were noisy.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.The returned device was visually inspected upon receipt and spine b was found stretched, with electrodes damaged and sharp.Spine cover was found torn.Per this condition the catheter outer diameters were measured and it was found within specifications.The polyurethane (pu) margins were found properly applied.Elongations marks were presented at the catheter spine.During manufacturing process all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage from leaving the facility.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter was evaluated for eeprom, carto 3, sensor functionality and electrical test; however catheter failed during carto and electrical test due to the physical damage presented.The customer complaint has been verified.Based on available analysis finding a result, the failure mode does not appear to be caused by any internal biosense webster, inc.Processes, since there was evidence of a proper manufacturing process as well as on line inspection are in place to detect this type of defects.

Manufacturer Narrative

Attention: (b)(6).Date: 03/08/2017.Subject: response to fda request for report 9673241-2016-00628.Fda follow up letter dated: 01/23/2017.(b)(4).Product description: pentaray nav eco high-density mapping catheter.This is a response to the fda¿s letter of a malfunction dated january 23, 2017 with the following event description: it was reported that a patient underwent an atrial tachycardia left (l-at) procedure with a pentaray navigational eco catheter.During the mapping phase, it was noticed that the catheter splines were damaged.It was reported that the splines of the catheter were somewhat physically disconnected.However, some wires kept part of the spline connected.There was also no visualization and the electrodes were noisy.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.The biosense webster failure analysis received the catheter for analysis.The returned catheter condition parallels the damage depicted, and includes additional damage such as sharp ring edges being exposed.The reported damage was assessed as mdr reportable as the risk to the patient was critical due to the potential of thrombus from exposure of internal catheter components, or risk of complete separation of the tip or tip component.Also, the discovery of sharp rings by the biosense webster failure analysis lab reflects that the catheter integrity is not maintained and there is potential harm to the patient.Therefore, this issue has also been assessed as mdr reportable.After reviewing the reported event provided in the fda letter received by biosense webster inc.(bwi), we have verified this event was originally reported to the fda under the pentaray nav eco high-density mapping catheter ((b)(4), report# 9673241-2016-00628).If the device did not function or perform as expected, please describe which device function or feature did not perform as intended, and the manner in which the device did not function as expected.Additionally, please discuss whether the unexpected function or behavior resulted in the event described.Response: the expected function of the pentaray nav eco product is that during mapping, the spines will not be damaged, the catheter tip should be visualized on the carto 3 system and the ecg signals should be of good fidelity.Customer reported that the spines of the catheter were somewhat physically disconnected.When the product was returned it was visually inspected and noted that none of the spines were neither disconnected nor were they partially detached.It was noted that spine b was found stretched, with electrodes damaged and sharp and the spine cover was torn.Two of the mapping electrodes on spine b were moved from their original location of spaced equally every 4 mm on the catheter tip.The tip material on spine b showed signs of stretching or elongation as evidenced by discoloration of the material.The length of spine b was measured and found to be 0.92 in long as compared to 0.66 in long for the other four spines indicating it had been stretched.This constitutes evidence of damage to the catheter.The electrical connection between two of the rings on spine b were disconnected as evidenced by the lead wire no longer being in contact with the rings.This will result in a loss of visualization as the carto 3 system¿s active current location technology requires an electrical connection to the mapping electrodes in order to function properly.This will also result in noise on the mapping electrodes as the electrical connection to the ring is removed.Therefore, the damage observed on the complaint will result in both a loss of visualization and noise on the ecg signals as was reported.At this time, it remains unknown how the catheter spine could be damaged by mapping.Please confirm or provide the model, lot, serial, and/or catalog number(s) of the device listed in the medical device report as applicable.Response: device: pentaray nav eco high-density mapping catheter, model# d-1282-07-s, lot# 17472938l, catalog# d128207.Please provide the total number of devices manufactured, distributed and, if available, used per year over the last three years for the medical device identified in the medical device report.Please indicate the proportions distributed in the us and outside the us.Response: device: model# d-1282-07-s, time period: jan-2014 to jan-2017.Total number of devices manufactured ¿ (b)(4).Total number of devices distributed ¿ (b)(4).Distributed in the us ¿ (b)(4).Distributed outside the us ¿ (b)(4).Total number of devices used ¿ information not available.Please provide the results for any investigation, evaluation, and/or failure analysis, including underlying cause identification, relevant to the reported event.Please include: an explanation for the reason for this occurrence based on your follow-up with the reporting facility or individual a complete description of investigation and analysis methodology(ies) used, an identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved, and any conclusions reached based on the investigation and analysis results.Response: the returned device was visually inspected upon receipt and spine b was found stretched, with electrodes damaged and sharp and the spine cover was torn.Per this condition, the catheter outer diameters were measured and were found within specifications.Polyurethane margins were found properly applied.Elongations marks were present at the catheter spine.During the manufacturing process, all catheters are inspected for visual damages before packaging.In addition, on line inspections are in place to prevent this type of damage from leaving the facility.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter was evaluated for eeprom, carto 3, sensor functionality and electrical test.The catheter failed during carto 3 and electrical tests due to the physical damage presented.The customer complaint has been verified.Based on available analysis findings, the failure mode does not appear to be caused by any internal bwi processes, since there was evidence of a proper manufacturing process as well as on line inspections to detect this type of defect.In addition, the failure mode does not appear to be caused by the sheath as the physician used a st.Jude medical sl0 fixed sheath during the procedure, which is compatible with this device.Please provide a complete list of medical device reports (mdrs) that you have determined are related to this same problem/issue.Please identify how many complaints (i.E.From all sources, including but not limited to field service records, repair history records, etc.) that your firm has received from january 1st, 2014 to january 23rd, 2017 that are related to this same reported device problem.Please provide manufacturer investigation/ conclusion details for every mdr and complaint.Response: between january 1st, 2014 and january 23rd, 2017, there have been a total of four other complaints that were reported for electrode damage, however no other complaints had the exact damage as reported in this complaint.Report 9673241-2015-00804 - reportable for electrode damage, 9673241-2015-00323 ¿ reportable for electrode damage and foreign material under rings, 9673241-2017-00048 ¿ reportable for electrode damage and foreign material under rings and 9673241-2015-00684 ¿ reportable for electrode damage.What quality control procedures and testing does your firm employ to ensure outgoing product meets design and performance specifications? describe acceptance and rejection criteria, and specify sampling procedures.Response: all pentaray tip/spines are 100% visually and/or dimensionally inspected in 4 steps of the manufacturing process: at the subassembly level where the tip is assembled.At the beginning of the final catheter assembly process.At the end of the final catheter assembly process.There is also an additional quality control step at the end of the process.All of the previously mentioned inspections includes: ring spacing and location, dimensions, visual inspection for damage and polyurethane glue condition on each ring, no drag marks, nicks dents and dings using a 10x magnification microscope.In addition to the visual and dimensional inspections, as part of the process, there is an electrical test performed to all rings in the spines that could also detect any malfunction or damage to rings or wires inside the assembly.What quality control measures are performed during manufacturing that are intended to prevent outgoing product from exhibiting the problems described in this report? were the reported device(s) subjected to any of these measures? response: all the pentaray catheters from lot number 17472938l, as described in the previous question # 6, were inspected.What actions has your firm taken to address this problem? response: complaint trends are monitored monthly; no significant trends have been identified at this time for the issues reported in this complaint and no actions have been taken.Biosense webster inc.Will continue to monitor these issues, along with all other issues reported to bwi.Please provide complete report on capa opened related to damaged or disconnect spine.Response: complaint trends are monitored monthly; no significant trends have been identified at this time for the issues reported in this complaint and no actions have been taken.Biosense webster inc.Will continue to monitor this issue, along with all other issues reported to bwi.(b)(4).

• Brand Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5988774
• MDR Text Key: 56799969
• Report Number: 9673241-2016-00628
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: D-1282-07-S
• Device Catalogue Number: D128207
• Device Lot Number: 17472938L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/28/2016; 03/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1