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

Catalog Number D134805

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis completed (b)(6) 2019.The device was inspected and reddish brown material was observed under the pebax.The rocker arm was detached and was not returned.During the second visual, a hole was observer in pebax.Internal parts were observed.The magnetic sensor functionality was tested on carto.The catheter was properly visualized, with no errors were observed.The force sensor feature was tested and it was found to be working properly.Force values were observed within specifications.A manufacturing record evaluation was performed, and no internal actions were identified.The customer complaint cannot be confirmed.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.However, this cannot be conclusively determined.The root cause of rocker arm detached could be related to the handling of the device during the shipment.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a hole in the pebax.Initially, it was reported that while ablating, force was observed high.Cable replacement resolved the issue.No adverse patient consequences were reported.The observed high force issue has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On (b)(6) 2019, the bwil pal received the device for evaluation.Upon initial inspection, reddish- brown material was observed under pebax.The observed reddish brown material has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.During a second visual inspection on (b)(6) 2019, the bwi pal observed reddish- brown material and a hole under the pebax.The observed hole has been assessed as an mdr reportable malfunction as internal components were exposed.The awareness date has been reset to (b)(6) 2019.

• 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9447462
• MDR Text Key: 199719878
• Report Number: 2029046-2019-03977
• 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: 09/16/2019

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: 06/12/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30233362M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2019
• 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