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

Model Number D134805

Device Problems Material Puncture/Hole (1504); High Readings (2459); Contamination /Decontamination Problem (2895)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

The product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection.And functional test of the returned device.Visual analysis of the returned sample revealed a foreign material inside the pebax of the thermocool® smart touch® sf bi-directional navigation catheter.The force sensor functionality test was performed, per bwi procedures.No force sensor issues were observed.During the force sensor functionality test, the device was displayed correctly.However, the foreign material inside the pebax could cause the force errors.The device was inspected on the pebax area, under microscopy, to identify if there was damage on the pebax that caused the foreign material inside the pebax.A hole was found in the pebax.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.It should be noted that device failure is multifactorial.The instructions for use contain the following precautions: flush the catheter with heparinized saline prior to insertion into the body.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the complaint were found during the review.The date of event was not provided.As such, the date of event has been populated with (b)(6) 2022.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturers ref.#: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that as soon as ablation was started, force went up to hi so tag index could not be displayed (error 88 and then 85).They tried doing a new zero and the problem happened again.They tried changing the cable and it did not fix the problem.We then changed the catheter and noticed there was blood inside the catheter in the transparent part.The procedure was completed after a 10 minute delay.No fragments were generated.There was no resistance during insertion and removal, but during use of the catheter when moving it around the cavity.The customers initial reported issues of high force readings and blood inside the pebax (transparent part) were assessed as not mdr reportable since the potential that these could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 15-aug-2022, the bwi pal revealed that a visual inspection of the returned device found a hole in the pebax.This finding was reviewed and assessed as an mdr reportable malfunction.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15369186
• MDR Text Key: 305918247
• Report Number: 2029046-2022-02137
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2022

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
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30749402L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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