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

Model Number D134804

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and evaluation has been completed.Bwi conducted a visual inspection and magnetic evaluation of the returned device.Visual analysis of the returned sample revealed a hole and reddish a material inside of the pebax.Magnetic sensor testing was performed, in accordance with bwi procedures.The catheter was working correctly, and no magnetic issues were detected during the analysis.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Although no conclusion could be reach on the cause of the reported event; it should be noted that for product magnetic failure, the instructions for use contain the following information in the carto 3 system manual that should be considered: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.The customer complaint regarding visualization issue was unable to duplicate during the product investigation.The device¿s pebax was found damaged with a hole and foreign material inside.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, but this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer reported visualization issue.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: membrane (g04088) were selected as related to the damage (hole) on the pebax.Manufacturer's ref.# (b)(4).

Event Description

A patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax.It was initially reported by the customer that the "catheter would move out of the plane when ablating." the grounding pad was replaced without resolution.The cable was replaced without resolution.The catheter was replaced, and the issue was resolved.The procedure was continued.There was no patient consequence.The customer¿s reported visualization issue is not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On (b)(6) 2021, the bwi product analysis lab received the complaint device for evaluation.On (b)(6) 2021, visual inspection found a reddish material inside the pebax and a hole was also found.This finding was assessed as an mdr reportable malfunction since the integrity of the device has been compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on (b)(6) 2021 and reassessed it as mdr reportable.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11790234
• MDR Text Key: 249705324
• Report Number: 2029046-2021-00725
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 02/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30470836M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• 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