MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found that the pebax appears to be torn.Second visual inspection was performed and a hole was found on the pebax.Then, a deflection test was performed and the catheter failed.Catheter was dissected and the deflection wire was found broken inside handle close to the piston.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.The root cause of puller wire broken cannot be determined.(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified the pebax to be torn with internal parts exposed.It was initially reported by the customer that during the afib operation, the catheter could not deflect (to the specification).The second catheter was used to complete the operation.There was no report on adverse event on patient.The customer¿s reported inadequate curve issue is considered to be not mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 5/1/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found that the pebax appears to be torn exposing internal parts.This finding was assessed as an mdr reportable malfunction since the device integrity was not maintained.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 5/1/2020 and reassessed this complaint as reportable.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10103368
• MDR Text Key: 195718382
• Report Number: 2029046-2020-00629
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30239946M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1