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

Catalog Number D133604IL

Device Problems Material Twisted/Bent (2981); Positioning Problem (3009)

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

Event Date 11/04/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to biosense webster (bwi) for evaluation.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed several kinks along the shaft.In addition, a hole on pebax's surface was found with reddish material inside it.The damages observed could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.A deflection test was performed, and despite the kinks observed, the curve was deflecting within specifications.No deflection issues were observed.A manufacturing record evaluation was performed for the finished device 31113091m number, and no internal action related to the complaint was found during the review.The deflection issue reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.On the other hand, the bent issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The damage on the pebax's surface is an issue unrelated to the event reported by the customer.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.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported deflection issue investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the bent shaft investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102)/ component code: sleeve (g04115) were selected as related to the hole on the pebax and the reddish material inside it 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: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) observed a hole on the pebax's surface with reddish material inside it.Initially, it was reported that during the operation, the catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient.A photo was provided which shows a bent shaft.However, no root cause can be determined without sample evaluation.As the customer stated that a sample is available for analysis, the complete evaluation will be documented when the sample is received.The deflection issue, as well as the bent shaft were assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completed on (b)(6) 2024, several kinks along the shaft were observed.In addition, a hole on the pebax's surface was noted, with reddish material inside it the hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 2024.

• 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: 18611514
• MDR Text Key: 334882112
• Report Number: 2029046-2024-00349
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2024

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 Catalogue Number: D133604IL
• Device Lot Number: 31113091M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2023
• 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