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); Peeled/Delaminated (1454); Dent in Material (2526)

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

Event Date 07/08/2016

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 during the procedure 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 since the catheter is unable to deflect or relax completely; the user will not be able to use the device and will have to replace it.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.On august 22, 2016, the device was received in the biosense webster failure analysis lab and during visual inspection it was discovered that the peek housing is bent on the proximal side of ring #3 leaving the ring rough and the polyurethane margin is peeling.This finding has been assessed as mdr reportable because if electrodes of catheter are dented, squashed, lifted or the pu border is damaged, then there is potential risk to the patient such as vascular dissection.The exposed rough edge is the damage creating patient risk.

Manufacturer Narrative

(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 during the procedure as the catheter could not deflect.The returned device was visually inspected upon receipt and the peek housing was found bent leaving the ring rough and the polyurethane margin peeling, which is why this complaint is mdr reportable.Further information received indicates that this condition was not observed during the procedure or prior to sending the catheter back.It may have happened while sending the catheter back to bwi.A scanning electron microscope (sem) test was performed and it was found that the body external surface presented evidence of scratching that might contributed to the bent condition.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.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.A deflection test was performed and the catheter passed even though the bent observed.The customer complaint cannot be confirmed.

• 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: 5952722
• MDR Text Key: 55172206
• Report Number: 9673241-2016-00597
• 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: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 17410914M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2016
• 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