MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1327-05-S

Device Problems Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The issue of the metal exposed in the tip lumen material approximately 3.5mm from the transition with the peek housing has been assessed as a reportable malfunction as the catheter integrity was not maintained in this area and internal components were exposed to the patient.The awareness date for this is april 27, 2016.The bwi failure analysis lab received the device for evaluation.The returned device was visually inspected upon receipt and it was found that peek housing and tip lumen transition was cracked with reddish brown material inside the area, also bumps were observed at catheter tip lumen and metal exposed which during an x-ray analysis it was determined that it was the t-bar which slid down and crossed the catheter lumen.It is also likely when the t-bar¿s slid down, it applied stress to the section and contributed to the peek housing cracked.Internal corrective action has been opened to investigate the peek housing issues.Due to the t bar was out of place, the deflection test failed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The reported customer complaint regarding a deflection issue has been verified.Internal corrective actions have been opened to investigate the peek housing issues and the t bar sliding down of its place.

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch bidirectional catheter.It was initially reported that the catheter could not be deflected as intended during the ablation for cavotricuspid ishmus (cti).The issue was resolved by changing the catheter.The procedure was completed without patient's consequence.This deflection issue is non-indicative of an mdr reportable event as the most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster failure analysis lab received the catheter for evaluation and discovered on april 27, 2016 the returned catheter condition.The peek housing and tip lumen transition was cracked with small amount of reddish brown material inside the area.Approximately 3.5mm from transition with peek housing, metal was exposed in the tip lumen material.On the opposite side, the tip lumen had bumps about 6mm from the transition with peek housing.Additional clarification has been requested on this returned catheter.However, no further information has been made available.The peek housing and tip lumen transition cracked with small amount of reddish brown material inside the area and the tip lumen had bumps about 6mm from the transition with the peek housing have both been assessed as not reportable issues as the catheter integrity was maintained and no internal components were exposed to the patient.The most likely consequence was an intraprocedural delay.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5680333
• MDR Text Key: 47292232
• Report Number: 9673241-2016-00338
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17222763M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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