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 Contamination (1120); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter left (l-afl) procedure with a pentaray navigational eco catheter and the bwi failure analysis lab noted the returned catheter condition of rings rough, sharp and material underneath the rings.It was originally reported that during the procedure, the pentaray navigational eco catheter was bent at the shaft upon opening it from the package.The procedure was completed with no patient consequence.Upon request, additional information was provided on the event.The physician was unable to insert the catheter into the sheath.They were unable to provide any additional clarification on the catheter condition.With the information available, this complaint was assessed as not reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The bwi failure analysis lab received the catheter and noted the returned catheter condition on (b)(6) 2015.Spine a had ring #3 squashed and on the proximal side of the ring, it had small amount white material underneath it.Ring # 4 was squashed, rough on the proximal side and had white material underneath it.Spine cover b had the marker ring lifted up and sharp.Ring #8 had the distal side with small area lifted up and sharp.Spine d had rings #14 and #16 squashed and dented.Ring # 15 was squashed and dented with a small amount of white material underneath the proximal side.Spine cover e had ring # 18 with a very small amount of white material underneath the proximal side.Rings #19 and #20 were both squashed down.Upon request, additional clarification was received on the returned catheter condition.It was confirmed that there was no patient consequence.This returned catheter condition was not noted.The white 8.5 fr agility sheath was used.

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.Manufacturer's ref.No: (b)(4).Event description continuation: this event was originally considered not reportable.However, bwi became aware of the returned catheter condition described as rings rough, sharp and material underneath rings on (b)(6) 2015 and have reassessed the event as reportable.Therefore, the awareness date for this record is (b)(6) 2015.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial flutter left (l-afl) procedure with a pentaray navigational eco catheter.It was reported that during the procedure, the pentaray navigational eco catheter was bent at the shaft upon opening it from the package.The procedure was completed with no patient consequence.The returned device was visually inspected upon receipt and no bent shaft was observed however it was found that several damaged electrodes were observed.Some of the rings were squashed and lifted up.Additionally, it a small amount of white material was found.An ft-ir was applied to identify the composition of the particles.Results showed that particles found underneath rings were abs and nitrile materials commonly used on plastic gloves.During the manufacturing process all the catheters are inspected for visual damages before packaging.Due to the electrodes condition and event reported, the catheter outer diameters were measured and it was found within specifications.Further information received indicated that the physician was unable to insert the catheter into the sheath.This condition might have contributed to the catheter damages.Per the event, the deflection test was performed and the catheter performed within specifications 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 customer complaint related to the bent on the catheter shaft cannot be confirmed.

• 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: shahe garabedian ; 15715 arrow hwy; irwindale, CA 91706 ; 9098397362
• MDR Report Key: 4799759
• MDR Text Key: 16629037
• Report Number: 9673241-2015-00323
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: D-1282-07-S
• Device Catalogue Number: D128207
• Device Lot Number: 17169227L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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