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 Bent (1059); Break (1069); Crack (1135); Kinked (1339); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the returned device was visually inspected upon receipt and a scratch and black foreign material was found in the pebax area.Per this condition a scanning electron microscope (sem) testing was performed over the damaged area of catheter and it was found that the pebax external surface presented evidence of and scratch induced by an unknown object; however no internal surface was exposed and no foreign matter was observed.Continuing with the visual inspection, the shaft was found bent and cracked with broken braid wires exposed.The rupture point might have happened while bending and unbending the product.An internal corrective action was created to address the thermocool smart touch broken shaft issue.During manufacturing all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.Due to the exposed braid, an electrical test was performed and catheter passed.Therefore, we can conclude all the electrical wires were perfectly insulated.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.

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (vt) procedure with a thermocool smarttouch uni-directional navigation catheter and a kink in the shaft occurred.After the successful vt ablation, the catheter was inspected outside the patient and a kinking of the shaft was observed.The case was completed without complications and there were no patient consequences.Upon request additional information was received on the event.The kink was at the first part of the catheter, at the "visualization" electrode.There was no difficulty in removing the catheter from the patient.There were no sharp edges or internal components of the catheter exposed.This event was originally assessed as not mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The catheter was returned to biosense webster failure analysis lab and it was discovered that the shaft was bent and cracked with broken braid wires exposed about 11cm from the distal end of the tip dome.There were additional non reportable findings; however this complaint is being reported due to the potential patient risk to the patient due to the exposed wires.The awareness date for this record is november 24, 2015 because that is when the damage was discovered.

• 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: joaquin kurz ; 9497893837
• MDR Report Key: 5306778
• MDR Text Key: 34583518
• Report Number: 9673241-2015-00936
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: D-1336-01-S
• Device Catalogue Number: D133601
• Device Lot Number: 17288954M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2015
• 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