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

Model Number D-1282-08-S

Device Problems Occlusion Within Device (1423); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2017

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.Manufacturer's ref.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray navigational eco catheter.There were no irrigation issues noted during mapping with this catheter.However, at the end of the procedure, the irrigation of the catheter became occluded during flushing.The catheter was removed but not replaced.The procedure was completed with no patient consequence with the ablation catheter.This irrigation issue was highly detectable by the physician.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was remote.Therefore, this issue was assessed as not reportable.The biosense webster failure analysis lab received the catheter for assessment on (b)(6) 2017.The initial visual inspection reflected that the product returned appeared to be in normal condition.However, after further assessment on (b)(6) 2017, electrode ring #14 was found squashed and sharp with foreign material.Since the electrode ring edge appears to be sharp, it may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.In addition, dislodgement of the foreign material inside the patient poses a risk of embolus.Therefore, the returned catheter conditions of the ring being sharp and the foreign material have both been assessed as reportable malfunctions.The awareness date of these conditions are (b)(6) 2017.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray navigational eco catheter.There were no irrigation issues noted during mapping with this catheter.However, at the end of the procedure, the irrigation of the catheter became occluded during flushing.The catheter was removed but not replaced.The procedure was completed with no patient consequence with the ablation catheter.The returned device was visually inspected and during the first visual inspection, the catheter appeared in normal condition.However, during the second visual inspection, ring # 14 was found squashed with sharp edges and with foreign material.Then per the reported event, an irrigation test was performed and the catheter failed.The catheter was dissected and it was found that the irrigation tubing was folded in the tip transition.It was also found that the triple lumen separated from the tip.Additionally, the catheter outer diameter was measured and it was found within specifications.For the condition observed, a scanning electron microscope (sem) testing was performed and the results showed evidence of mechanical damage on the surface of the ring.It is possible that damage was generated with an unknown object.No other anomalies were observed.Per material observed on the catheter tip, a fourier transform infrared spectroscopy (ft-ir) was performed and the results showed that material are primarily composed of silicon- based material presumably a siloxane commercially know as silicone.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.This issue was investigated and the external supplier was notified and changes were already implemented to reduce the complaints related with irrigation/occlusion issues.Complaint rate will be monitored thru the monthly complaints trending meeting.The customer complaint has been verified.The root cause of the irrigation tube folded cannot be determined.The root cause of the electrode damage cannot be determined since there is evidence that the catheter manufactured in accordance with documented specification and procedures.It could be related to the handling of the product, however, this cannot be conclusively determined.Per the ft-ir results, the foreign material reported could be polyurethane (pu), since it's part of the manufacture process of the electrodes parts.

• 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: 6843931
• MDR Text Key: 86608974
• Report Number: 9673241-2017-00675
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: D-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: 17664864L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1