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

Model Number D134703

Device Problems Material Puncture/Hole (1504); Insufficient Information (3190)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc for evaluation and the evaluation has been completed.Bwi conducted a visual inspection, and functional test of the returned device.On (b)(6) 2022, a visual analysis of the returned sample revealed a reddish material in the pebax and a hole in the pebax.The screening test was performed on carto, and the device failed.Error 106 was observed.The device was dissected on the tip area; loss of electrical continuity at the sensor was found, it was determined that the root cause was an internal failure of the sensor.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.The instructions for use contain the following warning stated in the carto 3 system manual: before use, check irrigation ports are patent by infusing heparinized normal saline through the catheter and tubing.Also, do not continue the use of the catheter if is not functioning properly or present physical damage.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The date of event was not provided.Date of event has been populated with (b)(6) 2022.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

Biosense webster inc.¿s (bwi) product analysis lab (pal) received a thermocool® smart touch® sf uni-directional navigation catheter which was identified to have a hole in the pebax.Upon receiving the thermocool® smart touch® sf uni-directional navigation catheter, visual inspection identified ¿a hole in the pebax¿ which is considered an mdr reportable malfunction.The thermocool® smart touch® sf uni-directional navigation catheter was returned labeled with a complaint number for which product details, such as the product catalog number and the lot number do not match.Multiple attempts have been made to obtain clarification for the wrong product received, however, no further information has been made available.A new complaint was created to investigate and report the malfunction found although no specific event details are available.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 2-sep-2022, it was noticed a incorrect reference number was reported in the 3500a initial medwatch report under section h10.Additional manufacturer narrative.The incorrect manufacture's ref # (b)(4).The correct manufacture's ref # is (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 15343578
• MDR Text Key: 305693341
• Report Number: 2029046-2022-02087
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: 10846835009798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

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 Expiration Date: 03/08/2023
• Device Model Number: D134703
• Device Catalogue Number: D134703
• Device Lot Number: 30735969L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2022
• 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