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

Catalog Number D133605IL

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an analysis was performed on the pictures provided by the customer.According to the pictures, catheter tip is observed undeflected, and piston up.Customer complaint is confirmed.The device was visually inspected and it was found transition between the peek housing and the tip lumen was cracked open with metal exposed.The tip lumen material has a white mark on it.Second visual was performed and the transition between the peek housing and the tip lumen is cracked open with metal exposed.The tip lumen material has a white mark on it; however, those damages were caused when the t-bar slid down.Then, deflection test was performed and the catheter failed.A failure analysis was performed and the catheter was observed under the x ray machine and the t bar was found slid down causing the improper deflection condition.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the t bar slippage and peek housing and tip lumen crack cannot be determined; however, an internal corrective action has been opened to prevent the issue.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 noted the transition between the peek housing and the tip lumen was cracked with metal exposed.Initially, it was reported that during the premature ventricular contraction (ve) procedure, the catheter could not deflect to specification.The second catheter was used to complete the procedure.There was no patient consequence reported.The curve inadequate issue was assessed as not reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and on october 3, 2019 it was noted that the transition between the peek housing and the tip lumen was cracked open with metal exposed.Also, the tip lumen material had a white mark on it.The returned condition of the transition between the peek housing and the tip lumen was cracked with metal exposed was assessed as a reportable issue.The awareness date for this issue is october 3, 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: 9245385
• MDR Text Key: 195043186
• Report Number: 2029046-2019-03765
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2020
• Device Catalogue Number: D133605IL
• Device Lot Number: 30229391M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1