MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problem Material Twisted/Bent (2981)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter facility name: thermocool® smart touch¿ electrophysiology catheter the picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that a patient underwent a pvc procedure with a thermocool® smart touch¿ electrophysiology catheter and the shaft was bent with difficulty upon maneuvering or during withdrawal.Shaft bent.During the procedure, the shaft on the catheter was bent.A second device was used to complete the operation.There was no adverse event reported on patient.Additional information was received.There was difficulty experienced while maneuvering the catheter or during the withdrawal.The abbott, 406849, 8.5f sheath was used.The shaft was able to be straightened up during the removal.

Manufacturer Narrative

It was reported that a patient underwent a pvc procedure with a thermocool® smart touch¿ electrophysiology catheter.Shaft bent.During the procedure, the shaft on the catheter was bent.A second device was used to complete the operation.There was no adverse event reported on patient.There was difficulty experienced while maneuvering the catheter or during the withdrawal.The shaft was able to be straightened up during the removal.The bwi product analysis lab received the device for evaluation on 21-nov-2023.The device evaluation was completed on 22-nov-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed no knotted condition; however, a bent mark was detected in the shaft area close to the tip section.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The failure observed could be related to the issue reported by the customer; therefore, the customer complaint was confirmed.The root cause of the bent mark could be related to the excessive force or manipulation of the device during the procedure; however, this can not be conclusively determined.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18112857
• MDR Text Key: 328627655
• Report Number: 2029046-2023-02604
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133604IL
• Device Lot Number: 31103279M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• 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: ABBOTT, (B)(6), 8.5F SHEATH.