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

Catalog Number D133604IL

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis completed 6/6/2019.The device was visually inspected, and the peek housing was observed kinked.During the second visual inspection the polyurethane (pu) border was observed separated from the ring edge.Electrical testing was performed on the catheter and it was found to be within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator.The temperature and impedance values were observed within specifications.On 6/6/2019, a manufacturing record evaluation was performed for the finished device and no internal actions were identified.The customer complaint cannot be confirmed.The root cause of the damage on the electrode, pu border, and the damage on the peek housing, 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.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found the polyurethane border separated from the ring edge.Initially, it was reported that during the afib operation, impedance could not be displayed.A second catheter was used to complete the operation.No adverse patient consequences were reported.The no impedance observed 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 5/15/2019, the bwi pal received the device for evaluation.Upon initial inspection, the peek housing was observed kinked.The observed kinked peek housing 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.Further testing was then performed.During a second visual inspection on 5/31/2019, the peek housing was found kinked.Although the ring was not damaged, the polyurethane border was observed separated from the edge of the ring, exposing internal parts.The observed polyurethane border separated from the ring has been assessed as an mdr reportable malfunction as device integrity was compromised.The awareness date was reset to 5/31/2019.

• 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 ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8733150
• MDR Text Key: 150174106
• Report Number: 2029046-2019-03326
• 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: 04/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2019
• Device Catalogue Number: D133604IL
• Device Lot Number: 30051534M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• 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