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

Model Number D-1348-04-S

Device Problems Break (1069); Hole In Material (1293); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned device was visually inspected and the shaft was observed damaged with some kinks with small opening with no metal exposed.Then, the catheter outer diameter was measured and it was found within specification.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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint has been verified.Based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes since the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the product, however, this cannot be conclusively determined.

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smarttouch® sf bi-directional nav catheter and an issue with the catheter tip was noticed as there was an unusual device shape/curve.The catheter was deformed on the distal part which can be deflected.There were no wires exposed, no lifted or sharp rings and no difficulty during insertion or removal of the catheter through the st jude agilis 8,5fr sheath.It was also noted that the catheter was not pre-shaped.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable because the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The device was returned and on (b)(6) 2017, the biosense webster failure analysis lab discovered that there was a small opening on the shaft with no metal exposed approximately to 15 inches from the handle.This finding is mdr reportable because if there is damage on the shaft that leads to wires exposed or cracks that disturb the integrity of the catheter, then there is a potential risk to the patient.The awareness date has been reset to (b)(4) 2017.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV 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: 6981813
• MDR Text Key: 91296575
• Report Number: 9673241-2017-00692
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: (01)10846835010176(11)161028(17)170930(10)17595440L
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• 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: 03/29/2017

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: 09/30/2017
• Device Model Number: D-1348-04-S
• Device Catalogue Number: D134804
• Device Lot Number: 17595440L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1