MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D131503
Medical Device Problem Codes	Crack (1135); Sharp Edges (4013)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).
Event or Problem Description
It was reported that a patient underwent a radiofrequency catheter ablation (rfca) procedure with a thermocool® sf nav uni-directional catheter for which the biosense webster, inc.Product analysis lab found electrode damage and the peek housing cracked with exposed parts.Initially it was reported that during the procedure, the catheter would not deflect.The catheter was replaced with another catheter and the procedure was completed.There was no patient consequence reported.The deflection issue 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.On january 9, 2020, the biosense webster, inc.Product analysis lab received the device for evaluation and upon initial visual inspection it was noted that the tip dome was flattened on one side with round area pushed in, the peek housing was cracked open with internal wiring exposed with ring 2 being squashed/dented, and some pins were found bent in the connector.This event was originally considered not mdr reportable, however, biosense webster, inc.Became aware of a reportable malfunction through second visual analysis on january 9, 2020 and have reassessed this complaint as reportable.Therefore, the awareness date for this reportable lab finding is january 9, 2020.
Additional Manufacturer Narrative
Investigation summary: it was reported that a patient underwent a radio frequency catheter ablation (rfca) procedure with a thermocool® sf nav uni-directional catheter for which the biosense webster, inc.Product analysis lab found electrode damage and the peek housing cracked with exposed parts.Initially it was reported that during the procedure, the catheter would not deflect.The catheter was replaced with another catheter and the procedure was completed.There was no patient consequence reported.The device was inspected, and the dome was observed to be dented and one ring lifted with no polyurethane (pu) on edge, the peek housing was broken, and some connector pins bent.A deflection test was performed, and it was found within specifications, the catheter was deflecting correctly.A manufacturing record evaluation was performed for the finished device [17736186l] number, and no internal actions related to the reported complaint condition were identified.The customer complaint cannot be confirmed since the device was deflecting correctly.The root cause of the damage observed along the catheter, cannot be related to the manufacture process.It could be related to the handling during shipment after procedure, however, this cannot be conclusively determined.Manufacturer's reference #: (b)(4).

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9657169
• Report Number: 2029046-2020-00173
• Device Sequence Number: 2784567
• Product Code: LPB
• UDI-Device Identifier: 10846835009293
• UDI-Public: 10846835009293
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030031/S034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2020
• Device Model Number: D131503
• Device Catalogue Number: D131503
• Device Lot Number: 17736186L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/02/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1