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

Model Number D-1336-01-S

Device Problems Break (1069); Crack (1135); Scratched Material (3020)

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

Event Date 05/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigational analysis has been completed.The returned device was visually inspected and it was found reddish material was found inside the pebax, near the proximal side of electrode ring #1.Scanning electron microscope (sem) results show that the external surface exhibited evidence of scratches, cracking and displacement material.It is possible that an unknown object hit and punctured the pebax.An internal corrective action has been opened to investigate this type of pebax damage.Per the complaint reported, the catheter was tested for deflection and the catheter failed.Afterwards, an x-ray of the catheter was taken and it was noticed that the t bar slid down from its place.The device history record (dhr) was reviewed and no anomalies were found.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.Internal corrective actions have been opened to investigate this type of pebax damage and the t bar issue.

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch unidirectional catheter, and during analysis it was found that the pebax was damaged.It was reported that the catheter stopped deflecting fully.The catheter was replaced and the issue resolved.A replacement catheter is being requested.The procedure was completed with no patient consequence.This issue has been assessed as not reportable since the catheter is unable to deflect fully, the user will not be able to use the device and will have to replace it.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.The bwi failure analysis lab received the product and initially noted that there was reddish brown material within the clear sleeve (pebax) on the proximal side of the electrode ring #1.However, since there was no damage discovered 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.Therefore, this issue was assessed as not reportable.After further analysis received on july 27, 2015, it was discovered that the pebax was found with evidence of scratches, cracking and displacement material.On july 29, 2015, the assessment clarified that it was possible that an unknown object hit and punctured the pebax.Since the integrity of the pebax was compromised as the pebax was cracking, it was assessed as a reportable malfunction.Therefore, the awareness date is july 27, 2015.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-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: shahe garabedian ; 9098397362
• MDR Report Key: 5032141
• MDR Text Key: 25575960
• Report Number: 9673241-2015-00564
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: D-1336-01-S
• Device Catalogue Number: D133601
• Device Lot Number: 17115306M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1