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

Catalog Number D133605IL

Device Problems Material Puncture/Hole (1504); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The returned device was visually inspected and found damage in the pebax as the pebax was broken leaving some internal components of the catheter tip exposed.After that, deflection test was performed, and the curve deflect correctly.A manufacturing record evaluation was performed for the finished device, and no internal action related to the complaint was found during the review.The deflection issue reported by the customer was not confirmed as no problem was found/detected.The root cause of the pebax broken 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.Cause could not be established for the broken material (pebax).The device was working correctly.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

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 a break in the pebax exposing internal components.It was initially reported by the customer that during the procedure, the catheter was unable to deflect or relax completely.A second catheter was used to complete the operation.There was no patient consequence.The reported deflection issue has been assessed as not reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 12/1/2020, the bwi product analysis lab received the complaint device for evaluation.During evaluation on 12/22/2020, the pebax was found broken leaving internal components exposed at the tip.This finding was assessed as an mdr reportable malfunction since the integrity of the device is compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 12/22/2020 and reassessed it as mdr 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11194945
• MDR Text Key: 257371995
• Report Number: 2029046-2021-00069
• 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: 10/19/2020

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: 11/03/2020
• Device Catalogue Number: D133605IL
• Device Lot Number: 30293951M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2019
• 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