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

Model Number	D134703
Medical Device Problem Codes	Material Puncture/Hole (1504); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• 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: 15343578
• Report Number: 2029046-2022-02087
• Device Sequence Number: 4574984
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: 10846835009798
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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
• Patient Sex: Unknown