MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133605IL

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the device was inspected, and the helix spring was found contorted, then, during the second visual inspection the helix spring was found bent with no exposed parts.Pebax was found without damage.Pu damage in electrode #2, a part of the pu was found missing on the ring edge.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed 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 the pu that cover the electrode ring cannot be determined 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, however, this cannot be conclusively determined.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent an unknown procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab found polyurethane (pu) missing on electrode number 2.Initially it was reported that the electrode on the thermocool® smart touch¿ electrophysiology catheter was broken.A second catheter was used to complete the procedure and there was no patient consequence.(b)(6) complaints are reported using the similar verbiage of the ¿electrode broken¿ when they have signal issues on the electrode.Therefore, the failure to capture electrical signal from an electrode was assessed as not reportable as the risk to the patient was low.The biosense webster, inc.Product analysis lab received the device for evaluation and found on january 7, 2019 that the helix spring was contorted.The contorted helix spring was assessed as a not reportable issue.The device integrity was maintained, and no internal components were exposed to the patient.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.After further evaluation on february 8, 2019, it was confirmed that the helix spring was found bent with no exposed parts.The pebax was found without damage.There was pu damage on electrode #2 as part of the pu was missing on the edge of ring #2.The issue of the helix spring remains not reportable.The pu missing on the electrode was assessed as reportable.The awareness date for this reportable lab finding was february 8, 2019.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8404594
• MDR Text Key: 141605899
• Report Number: 2029046-2019-02770
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2019
• Device Catalogue Number: D133605IL
• Device Lot Number: 30076365M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Date Manufacturer Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2018
• 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