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

Model Number	D132704
Medical Device Problem Codes	High Readings (2459); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 4-sep-2021.The device evaluation was completed on 4-oct-2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and a carto-force test on the returned device.Visual analysis of the returned sample revealed a cut on the pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related with the handling since in the process, there are control inspection points to avoid these kinds of issues.Force testing was performed and observed that the catheter was displayed properly.The evaluation determined that the cause of the pebax damage failure cannot be established.However, the blood found inside the pebax area may have contributed to the high force issue reported.A manufacturing record evaluation was performed for the finished device 30533700m number, and no internal action was found during the review.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following warning stated in the carto 3 system manual: -for force issue of the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.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 or Problem Description
It was reported that patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed a cut on the pebax with reddish-brown material inside.Initially.It was reported that during ablation, force readings on the catheter went up to 70 grams.There was no impedance rise when this happened.The cable was exchanged, and the issue persisted.The catheter was exchanged, and the issue was resolved and the case was completed without any further incident.There was no patient consequence.The high force issue was assessed as not mdr reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.This event is being reported because the biosense webster, inc.Product analysis lab received the device for evaluation and found that there was a cut on the pebax with reddish-brown material inside and internal parts exposed.The issue was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 4-oct-2021.

• Brand Name: THERMOCOOL SMART TOUCH 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
• MDR Report Key: 12710116
• Report Number: 2029046-2021-01836
• Device Sequence Number: 4239268
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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: 04/25/2022
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30533700M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER