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

Catalog Number D134805

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The device was inspected, and reddish color was observed under pebax on distal tip.Second visual inspection was performed and found the reddish material inside the pebax and a hole was observed in the pebax.Per the event, the catheter was tested for electrical performance and it was found within specifications.A manufacturing record evaluation was performed and no internal actions related to the reported complaint 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.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab has identified a hole on the pebax.It was initially reported by the customer that noise displayed on the ablation signals on both the carto 3 and the recording system.The cables were replaced without resolution.The catheter was replaced and the issue resolved.The case continued without further incident or harm.The customer¿s reported incident is not considered to be mdr reportable since the risk to the patient is low.On 10/14/2019, the bwi product analysis lab received the device for evaluation.Initial visual analysis observed reddish color is observed under pebax on distal tip.This finding was not considered to be mdr reportable since there is no damage to the pebax integrity that could cause the foreign material travels into the blood circulation.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 11/5/2019, during a second visual analysis, the reddish material in the pebax was observed along with a ¿hole¿ in the pebax.These findings were reviewed and determined to be a reportable malfunction since the integrity of the device is compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction on 11/5/2019 and has reassessed this complaint as 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9375878
• MDR Text Key: 195389570
• Report Number: 2029046-2019-03927
• 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: 10/02/2019

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: 07/08/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30256054M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2019
• 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