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

Catalog Number D134722IL

Device Problems Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535); Application Program Problem (2880)

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

Event Date 01/07/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster inc, (bwi) product analysis lab observed a reddish material in the pebax, and a hole was found.Initially, it was reported that during the operation, the force value could not be zeroed.A second catheter was used to complete the operation.No adverse patient consequences were reported.The force and unable to map issues were assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation on 22-feb-2022, and found on 21-mar-2022, that there was a reddish material observed in the pebax and a hole was found.The hole on the pebax was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 21-mar-2022.

Manufacturer Narrative

Initial reporter phone: (b)(6).According to the pictures provided by the customer, force readings around 52g and the error 319 were observed on carto 3 screen.The customer complaint was confirmed based on the picture received.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and force evaluation of the returned device.Visual analysis of the returned sample revealed that a reddish material was observed in the pebax, and a hole was found on the thermocool® smart touch¿ electrophysiology catheter.Magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested, and it was working properly, the force values were observed within specifications.The evaluation determined that the cause of pebax damage failure cannot be established.The event described as force issue was unable to be duplicated during the product investigation.However, the blood found inside the pebax area may have contributed to the force issue reported.A manufacturing record evaluation was performed for the finished device 30620711l number, and no internal action was found during the review.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following warning stated in the carto 3 system manual: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.Regarding the additional finding observed, the instruction for use contains the following information: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under pma # p030031/s053.(b)(4).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: 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14138064
• MDR Text Key: 290153239
• Report Number: 2029046-2022-00838
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2022
• Device Catalogue Number: D134722IL
• Device Lot Number: 30620711L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK BRAND CATHETER