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

Model Number D-1336-05IL-S

Device Problem Material Integrity Problem (2978)

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

Event Date 10/10/2015

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 smart touch unidirectional catheter.The product was received by the biosense webster failure analysis lab and it was discovered that the integrity of the catheter was not maintained.Initially, it was reported that during the procedure, the catheter would not deflect.The catheter was changed.The procedure was completed with no patient consequence.Since the catheter was unable to deflect, the user will not be able to use the device and will have to replace it.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.Therefore, this issue was assessed as not reportable.The product was received for analysis in the biosense webster failure analysis lab and it was discovered on november 13, 2015 that the shaft was bent with a sharp braid wire and internal parts exposed about 11mm from the transition tip lumen.Since the catheter integrity was not maintained and internal components were exposed to patient, this returned catheter condition has been assessed as a reportable malfunction.The awareness date was reset to november 13, 2015.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a smart touch unidirectional catheter.During the procedure, the catheter would not deflect.The catheter was changed.The procedure was completed with no patient consequence.The returned device was visually inspected upon receipt and it was found that the shaft was broken with sharp braid and internal parts exposed.Further information received indicates that sheath used during the procedure was smaller (8fr) than the recommended by the instructions for use (8.5 fr).This might have contributed to the catheter damage.An internal corrective action has been opened to investigate the thermocool smart touch broken shaft issue.The catheter was tested for deflection and the catheter failed.Afterwards, the catheter was dissected and the puller wire was found broken at the handle area causing the deflection issue.Further investigation found that the polyamide was bonded to the side arm 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.An internal corrective action has been opened to investigate the thermocool smart touch broken shaft issue.

• 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 ; 9497893837
• MDR Report Key: 5288119
• MDR Text Key: 33902999
• Report Number: 9673241-2015-00909
• 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: 10/12/2015

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: 11/30/2015
• Device Model Number: D-1336-05IL-S
• Device Catalogue Number: D133605IL
• Device Lot Number: 17130191M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2014
• 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