MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D134802
Medical Device Problem Codes	Image Orientation Incorrect (1305); Material Puncture/Hole (1504); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: conclusion: according to the information received, it was reported that the carto 3 system was displaying high force reading when going on ablation.Caller noted that the force vector was pointing straight back while the smart touch bidirectional sf device was connected.The device was returned to biosense webster for evaluation.A visual inspection and screening test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed that the pebax was damaged and foreign reddish material was observed inside.A screening test was performed, and the device was visualized and recognized correctly; however, the force vector was observed inverted and hi force was displayed, since the sensor values were found within specifications, this issue could be related to the blood inside the pebax, however, the root cause of the damage could not be determined, but it was concluded that it occurred outside the bwi manufacturing facilities.A manufacturing record evaluation was performed for the finished device 30662393l, and no non-conformance was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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.No capa activity is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Device history lot: mre review: a manufacturing record evaluation was performed for the finished device 30662393l, and no non-conformance was found during the review.Manufacturing date: 16-oct-2021.Expiration date: 15-oct-2022.Device history batch: null.Device history review: null.
Event or Problem Description
A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax with reddish material inside.The finding was identified on 13-apr-2022.During the procedure, the carto 3 system was displayed a high force reading when going on ablation.Additionally, the force vector was pointing straight back.The catheter was replaced, and the issue was resolved.The procedure was continued.No patient consequences were reported.High force is not mdr-reportable.Force vector orientation issue is not mdr-reportable.Hole in the pebax is mdr-reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14333088
• Report Number: 2029046-2022-00975
• Device Sequence Number: 5236883
• Product Code: LPB
• UDI-Device Identifier: 10846835010152
• UDI-Public: 10846835010152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2022
• Device Model Number: D134802
• Device Catalogue Number: D134802
• Device Lot Number: 30662393L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2022
• Supplement Date Received by Manufacturer: 05/08/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM
• Patient Sex: Unknown