MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133602

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.Investigation summary: the device was visually inspected and it was found in good conditions; however, during the second visual inspection reddish material was observed inside the pebax.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.During testing, no temperature was observed.For that reason, the force feature cannot be tested; however, during the carto test no force issues were observed.Then, electrical test was performed on the catheter and it was found within specifications; however, the thermocouple values were found out of specifications.A failure analysis was performed and it was found that there is an open circuit on the tip area creating the temperature issue.Additionally, a scanning electron microscope (sem) testing was performed on the pebax area and the results showed damage in form of peeling.Pebax material presents a deformation similar to heat melting; however, root cause cannot be determined.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.The temperature issue does not represent any patient safety impact since the device is unable to deliver radio frequency energy to ablate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab discovered that the pebax presented damage in the form of peeling.Initially, high force appeared when trying to ablate.The cable was exchanged; however, the issue remained.After, they recalibrated to zero and this also did not resolve the issue.The catheter was changed and the issue resolved.There was no patient consequence reported.The high force issue was assessed as not reportable.This 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.The biosense webster inc.Product analysis lab received the device for evaluation and during the second visual inspection on 8/23/2019, it was noted that there was reddish material inside the pebax.This returned condition was assessed as not reportable as there was no noted damage to the pebax integrity.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.On 9/4/2019 a scanning electron microscope (sem) was performed and the results revealed that the pebax area presented damage in form of peeling.The pebax material presented a deformation similar to heat melting; however, the root cause could not be determined.This pebax condition was assessed as a reportable malfunction as the integrity of the device was compromised.The awareness date for this reportable issue is 9/4/2019.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 9088261
• MDR Text Key: 159690145
• Report Number: 2029046-2019-03654
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2020
• Device Catalogue Number: D133602
• Device Lot Number: 30198675M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2019
• 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