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

Model Number D-1327-04-S

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Concomitant product: preface sheath.Model #: unknown.Lot #: unknown.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch bidirectional catheter.The catheter would not deflect towards the curves.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.This reported issue was assessed as not reportable 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 product for analysis and discovered on (b)(6) 2016, that the peek housing and tip lumen transition had a small open bubble and a small broken wire was sticking out allowing some reddish brown material inside.The tip lumen had bumps in two areas.First one was about 4.5mm and the second one about 6mm from the transition with the peek housing on the other side.No metal was exposed.Additional clarification was requested and received on this returned catheter condition.The 8f preface sheath was used.There was difficulty experienced while maneuvering the catheter as the catheter would not move to the curve.This condition was noted during the procedure.The issue with the bumps are assessed as not reportable as there was no exposure of internal components or any evidence that the integrity of the catheter was being compromised.Therefore, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event was remote.The issue with open bubble was assessed as a reportable malfunction as it has an exposed wire.Therefore, the risk to the patient was critical due to the potential of thrombus formation from exposure of internal parts of the catheter.The awareness date was reset to (b)(6),2016.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch bidirectional catheter.The catheter would not deflect towards the curves.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence the returned device was visually inspected and it was found a small bubble with small broken wire sticking out allowing some reddish brown material inside the peek housing and tip lumen transition.Also bumps were observed at catheter which during the analysis it was determined that the t-bar of both curves slid down and applied stress to the section and contributed to the peek housing cracked and bumps observed.Further investigation revealed residues of pu application at the t-bar anchored place which indicates a proper manufacturing assembly.Due to the t bars being out of place, 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 catheter failed deflection tests; however the root cause of the t-bar displacement cannot be determined.There was evidence of a proper manufacturing assembly.The t-bar issues could be related with the small broken wire seen in the 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6109500
• MDR Text Key: 60696918
• Report Number: 9673241-2016-00789
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: (01)10846835009194(11)160829(17)170731(10)17553165M
• 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
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: D-1327-04-S
• Device Catalogue Number: D132704
• Device Lot Number: 17553165M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2016
• 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