MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1336-04IL-S

Device Problems Bent (1059); Component Missing (2306); Device Operates Differently Than Expected (2913)

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

Event Date 09/19/2016

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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool smarttouch uni-directional navigation catheter and a deflection issue occurred as the catheter could not deflect.The catheter was changed and the procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable because the potential risk that it could cause or contribute to a serious injury or death is remote.The device was returned to biosense webster failure analysis lab on october 26, 2016 and it was discovered that the tip section was bent at the helix spring inside the clear sensor sleeve, causing a piece of the sleeve to be missing, and leaving the helix spring exposed.Multiple attempts have been made to obtain clarification to this returned catheter condition.However, no further information has been made available.This finding is mdr reportable because if internal parts are exposed, then the risk to the patient is critical due to the potential of thrombus formation from exposure of internal parts of the catheter.The helix spring is exposed in this case.The awareness date for this record is october 26, 2016 because that is when the reportable finding was discovered.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4) it was reported that a patient underwent an ablation procedure with a thermocool® smarttouch® uni-directional navigation catheter and a deflection issue occurred as the catheter could not deflect.Upon receiving, the catheter was visually inspected and the pebax presented a rupture with the helix exposed, which is why this complaint was mdr reportable.Per this condition, scanning electron microscope (sem) testing was performed over the area and it found evidence of scratching and rupture.It is possible that an unknown object hit and ruptured the pebax.A tilt test was performed and the catheter failed; however during the manufacturing process 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.Per the complaint, 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 catheter was dissected and residues of polyurethane application were found at the t-bar anchored place, dacron assembly was in correct position which indicates a proper manufacturing assembly.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.The root cause of the catheter t-bar displacement cannot be determined since there was evidence of the appropriate manufacturing assembly.Regarding the pebax damage, based on available analysis results the procedural/handling factors may contribute to the catheter failure and the pebax rupture.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 6119521
• MDR Text Key: 60933634
• Report Number: 9673241-2016-00809
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 17464896M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2016
• 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