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

Catalog Number D133604IL

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

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

Event Date 12/29/2021

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 17-feb-2022.The investigation was completed on (b)(6) 2022.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and deflection test of the returned device.Visual analysis of the returned sample revealed reddish material and a hole in the pebax with internal parts exposed.Deflection testing was performed in accordance with biosense webster, inc.Procedures.The deflection mechanism passed the test.The curve met the specification.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was found with the deflection curve within specifications.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.(b)(4).Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab observed a hole in the pebax with internal parts exposed.Initially a deflection issue was reported.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 per the evaluation completion on (b)(6) 2022 there was reddish material and a hole in the pebax with internal parts exposed.The hole on the pebax with internal parts exposed was assessed as mdr reportable for "foreign material inside the pebax with external damage".The awareness date for this reportable lab finding was (b)(6) 2022.

• 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: 13906669
• MDR Text Key: 290454631
• Report Number: 2029046-2022-00632
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2022
• Device Catalogue Number: D133604IL
• Device Lot Number: 30577322M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2021
• 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