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

Catalog Number D133604IL

Device Problem Material Separation (1562)

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

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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.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.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 a supraventricular tachycardia (svt) ablation procedure with an thermocool® smart touch¿ electrophysiology catheter and the catheter¿s shaft was broken.It was reported that during the operation, the shaft on the catheter was broken (no exposed wires) when it was used.A second device was used to complete the operation.There was no adverse event reported on patient.Additional information was received indicating the damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter is not pre-shaped.There was no partial or total detachment due to the stated issue.The device was removed from patient's body by pulling it out from the patient's body along with the sheath.

Manufacturer Narrative

On 21-dec-2022, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with an thermocool® smart touch¿ electrophysiology catheter and the catheter¿s shaft was broken.It was reported that during the operation, the shaft on the catheter was broken (no exposed wires) when it was used.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and deflection evaluation of the returned device was performed following bwi procedures.Visual analysis revealed a kink at the shaft at 39 in from the handle.No exposed wires were detected.The root cause of the shaft bent cannot be determined, it could be related to the handling of the device, however, this cannot be conclusively determined.Unit was inspected prior leaving the facility as there are functional tests and inspections at control points based on the process to avoid this type of damage from leaving the facility.The bent shaft condition could be related to the reported issue by the customer additionally, according to the x-ray photo provided by the customer, the body shaft of the catheter was observed bent, no exposed wires were observed on the x-ray photo provided.The bent condition observed on the device could be related to the customer complaint; however, this cannot be conclusively determined.No other damages or anomalies were observed during the photo analysis.The customer complaint was also confirmed based on the picture received.A manufacturing record evaluation was performed for the finished device, and no internal action related to the reported complaint condition were identified.The issue reported by the customer was confirmed.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16011701
• MDR Text Key: 308458164
• Report Number: 2029046-2022-03183
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30821773M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THMCL SMARTTOUCH,TC,D,C3,OBL.