MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1197-17-S

Device Problem Bent (1059)

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

Event Date 11/13/2015

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 a procedure with a navistar® thermocool® electrophysiology catheter and a bent tip was observed.The catheter was not used on the patient.The catheter was replaced and the procedure was completed with no patient consequence.Upon request additional information was received on the event.After opening the package, the doctor found the tip of the catheter was bent.The damage did not result in wires being exposed.The catheter was not pre-shaped.This event was originally assessed as not mdr reportable because the bent was minimal with no compromise to catheter integrity therefore the potential risk that it could cause or contribute to a serious injury or death is remote.The biosense webster failure analysis lab received the device for evaluation on january 5, 2016 and during visual inspection it was discovered that the tip of the catheter was bent approximately 117cm from the handle.In addition, electrode #3 is protruding because of the bent tip.Rough edges are formed from the protrusion.Therefore this complaint was reassessed as mdr reportable due to the rough edges, because rough edges could potentially cause patient harm.The awareness date for this record is january 5, 2016 because that is when the rough edge was discovered.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a navistar® thermocool® electrophysiology catheter and a bent tip was observed.Upon receipt, the catheter was visually inspected and the tip of the catheter was found bent, due to this condition electrode #3 was found to be protruding and with rough edges, which is why this complaint was reported to the fda.The outer diameters were measured and found within specifications.Catheter was introduced in an instructions for use recommended sheath and no resistance was noticed during the procedure.Further investigation performed along with the manufacturing team and based on the picture provided by the customer it was found that the damage seems to have originated when the catheter was pulled out from the container since stress marks were observed at the catheter packaging based that can be associated with this damage.The device history record 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.Based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes; since product is 100% verified for the issue reported at two control points during manufacturing as well as during packaging process.

• Brand Name: NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 5407841
• MDR Text Key: 38088143
• Report Number: 9673241-2016-00059
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• 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,Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: D-1197-17-S
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 17180971M
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• 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