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

Catalog Number D133604IL

Device Problems Positioning Problem (3009); Material Split, Cut or Torn (4008)

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

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).¿investigation findings code of appropriate term/code not available represents photo/video analysis.¿ the evaluation was completed on 02-jul-2021.A picture showing the catheter was received for analysis.The photo does not provide sufficient information related to the reported event as the piston is not up, and therefore, no result can be obtained from it.Customer complaint cannot be confirmed.The product analysis was performed as appropriate in order to find the root cause of the complaint.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection test of the returned device.Visual analysis of the returned sample revealed a cut on the pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related with the handling since in the process there are control inspection points to avoid this kind of issue.The evaluation determined that the cause of the pebax damage failure cannot be established.Deflection test was performed.In accordance with bwi procedures, the catheter failed the test since it was not deflecting.Therefore, the catheter was dissected from the handle.It was determined that the puller wire was broken inside the handle causing the improper deflection condition.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwis quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer's reference #: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool¿ smart touch" electrophysiology catheter and the biosense webster, inc.Product analysis lab received the device for evaluation and observed a cut on the pebax with internal parts exposed.Initially it was reported that during the procedure, the catheter was unable to deflect or relax completely.A second catheter was used to complete the procedure.There was no patient consequence reported.The deflection issue was assessed as not mdr reportable.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and observed on (b)(6) 2021 a cut on the pebax with reddish-brown material inside and internal parts exposed.The returned condition of the cut on the pebax with internal parts exposed was assessed as mdr reportable.The awareness date of the reportable lab finding is (b)(6) 2021.

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12223114
• MDR Text Key: 263440591
• Report Number: 2029046-2021-01168
• 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: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2022
• Device Catalogue Number: D133604IL
• Device Lot Number: 30485530M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Date Manufacturer Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2021
• 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
• Treatment: UNKNOWN BRAND CATHETER