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 No Display/Image (1183); Cut In Material (2454); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a smart touch bidirectional catheter, and during the bwi failure analysis lab review of the catheter it was noted that the pebax integrity had been compromised.It was reported that the temperature of the catheter was not displayed.Also, the ablation could not be conducted when the ablation was started after inserting the catheter into the cardiac cavity.The generator was rebooted and the cable was changed but the issue continued.The issue was resolved by changing the catheter.The procedure was completed without patient consequence.These reported issues were assessed as not reportable as the potential that they could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event is being reported because the bwi failure analysis lab received the device for evaluation and found the clear sensor sleeve (pebax) had a cut with a small hole.No liquid or stains were found inside the sleeve.This finding is reportable because the pebax integrity has been compromised.The awareness date for this record is april 29, 2015.Additional clarification on the returned catheter condition has been received.There was no information that this product was withdrawn from the patient with difficulty that may have caused this returned catheter condition.There is no information on which sheath was used.There is no information if this condition was noted when this product was returned to the bwi failure analysis lab.

Manufacturer Narrative

(b)(4).The returned device was visually inspected upon receipt and it was found that the clear sensor sleeve (pebax) had a cut with small hole.A scanning electron microscope (sem) testing was performed over the damaged area of catheter and it was found that the edges from the rupture/broken section presented evidence of elongation at the surroundings areas of the separation.Elongation is a common characteristic of pieces which were stretched/bent until separation.An internal corrective action has been opened to investigate the pebax damage on the smart touch catheter.Then per the event reported, the returned device was evaluated for electrical resistance and the thermocouple test failed.Further examination revealed that the thermocouple wires were broken at the tip section.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 customer complaint has been verified.An internal corrective action has been opened to investigate the pebax damage on the smart touch catheter.

• 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 3259 9; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4772831
• MDR Text Key: 5781073
• Report Number: 9673241-2015-00288
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2015

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: 11/30/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17149627M
• Other Device ID Number: (01)10846835009200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2014
• 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