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); Break (1069)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/15/2015

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a smart touch unidirectional catheter.Initially, the deflection was found inadequate during the procedure as the catheter could 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 has been assessed as not reportable.The biosense webster failure analysis lab discovered on november 13, 2015 that the shaft was bent and wrinkled with broken braid wire exposed about 5mm from the transition with the tip lumen.Request was made to obtain clarification to this returned catheter condition.However, no further information has been made available.Since the catheter integrity was not maintained and the internal components were exposed to the patient, this issue 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.The deflection was found inadequate during the procedure as the catheter could not deflect.The catheter was changed.The procedure was completed with no patient consequence.Upon receipt, the catheter was visually inspected and shaft was found bent, wrinkled with broken braid exposed.Further information was requested regarding the condition of the catheter; however it has not been available for biosense webster.It appears that the damage was due to external force while bending and unbending the area.An internal corrective action has been opened to prevent these type of issues.A deflection test was performed and the catheter passed.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 cannot be confirmed.An internal corrective action has been opened to prevent the broken shaft issues.

Manufacturer Narrative

On april 5, 2016 additional information was received on the request for clarification on the returned catheter condition.There was no resistance or difficulty during insertion or removal of the catheter.It was not reported if the catheter was pre-shaped.The sheath information was not reported.There was no information if this issue had been noticed before use, during use or post use.Manufacturer's ref.No: (b)(4).

• 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: 5321803
• MDR Text Key: 34922741
• Report Number: 9673241-2015-00959
• 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,Followup
• Report Date: 10/21/2015

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: 04/30/2016
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 17231221M
• 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: 10/21/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/28/2016; 04/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2015
• 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