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

Model Number D134805

Device Problem Break (1069)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The tip of the catheter was reported as broken.The tip of the catheter is broken as it passes through the aorta.No delay, the catheter was changed and the procedure was successfully completed.No patient consequences were reported.No medical intervention was required.The damage did not result in wires being exposed or any lifted or sharp rings, only catheter distal tip was broken.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.Sheath used was a mobicath guiding sheath 8.5f.The broken tip is mdr-reportable.

Manufacturer Narrative

On 15-sep-2021, the bwi product analysis lab received the device for evaluation.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On (b)(6)2021, the product investigation was completed.It was reported that an unknow patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The tip of the catheter was reported as broken.The tip of the catheter is broken as it passes through the aorta.No delay, the catheter was changed and the procedure was successfully completed.No patient consequences were reported.No medical intervention was required.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection evaluation of the returned device.Visual analysis of the returned sample revealed a hole on pebax and spring helix broken observed on the stsf catheter.A manufacturing record evaluation was performed for the finished device 30500518l number, and internal action related to the complaint 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 recommendations: the sterile packaging and catheter should be inspected prior to use.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® SF BI-DIRECTIONAL NAVIGATION 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12390008
• MDR Text Key: 268901506
• Report Number: 2029046-2021-01445
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P030031
• 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,Followup,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30500518L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• 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: MOBICATH GUIDING SHEATH 8.5F; MOBICATH GUIDING SHEATH 8.5F