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

Model Number D134805

Device Problems Display or Visual Feedback Problem (1184); Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on 18-jun-2021.The catheter was returned to biosense webster for evaluation.Bwi conducted a visual inspection, c3 system, and spi screening test of the returned catheter.Visual analysis of the returned catheter revealed reddish material inside and a hole in the pebax of the thmcl smtch sf catheter.C3 system and shaft proximity interference (spi) screening test was performed, in accordance with bwi procedures.The returned sample was connected to the carto 3 system and the force values were observed within specifications.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified as part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The evaluation determined that the cause of pebax damage failure cannot be established.The events described visualization and force issue were unable to duplicate during the product investigation; however, the blood inside the pebax area found could be related to the reported issue.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed a hole on the pebax with internal parts exposed.Initially it was reported that the thermocool® smart touch® sf bi-directional navigation catheter vector appeared erratically, unable to re-zero only reached 5 grams on the carto 3 system.The physician was in and out of the transseptal sheath 5 times with the catheter.The physician ensured the catheter was out of sheath but the caller stated it was way out in the left pulmonary veins, and appeared as though the agilis sheath was as well.The physician had a difficult transseptal as lost access three times.There were normal metal values on the carto 3 system.To troubleshoot, they exchanged the catheter with one from the same lot and the issue persisted.They exchanged the ablation cable with a new non-reprocessed cable without resolution.They rebooted the carto 3 system without cables connected and changed grounding patches without resolution.They exchanged the catheter with one from a different lot and the physician simultaneously pulled it back into right atrium, catheter was in ivc and it zeroed fine.All issues resolved.The procedure was completed without patient consequence.They were unsure if the issue was catheter related (bad lot) or system related.The visualization issue was assessed as not mdr reportable.If the device is not visualized by the carto 3 system, the user will have to replace the catheter in order to complete the case.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The force issue was assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and on (b)(6) 2021 a hole was observed on the pebax with reddish-brown material inside and internal parts exposed.The hole on the pebax with internal parts exposed was assessed as mdr reportable.The awareness date for this biosense webster, inc.Product analysis lab finding is 18-jun-2021.

• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12170976
• MDR Text Key: 262224228
• Report Number: 2029046-2021-01125
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• 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: 30506831M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Date Manufacturer Received: 06/18/2021
• 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