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); Positioning Problem (3009); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2015

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.As lot # 17024450m was provided, the device history record(s) 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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool marttouch uni-directional navigation catheter and during the procedure catheter could not deflect, which is not indicative of an mdr reportable event.Replacement catheter was used to complete the procedure without patient consequence.On (b)(6) 2015, bwi received the product back and the failure analysis laboratory found that pebax had small tears between rings 1 and 2 exposing helix coil from inside and helix coil is bent causing tip to bend.This event is being reported because the pebax integrity is compromised and could potentially contribute in an adverse event.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® uni-directional navigation catheter and during the procedure catheter could not deflect, which is not indicative of an mdr reportable event.Replacement catheter was used to complete the procedure without patient consequence.On july 6th 2015, bwi received the product back and the failure analysis laboratory found that pebax had small tears between rings 1 and 2 exposing helix coil from inside and helix coil is bent causing tip to bend.This event is being reported because the pebax integrity is compromised and could potentially contribute in an adverse event.The bwi failure analysis lab received the device for evaluation.Upon receipt, sem analysis was performed to the catheter and the sem results shows that the external surface of the exhibit has evidence of two pinholes.It is possible that an unknown object punctured the pebax and causes the pinholes.Additional information received stated that the tip bent was noticed after procedure.This may suggest that the bent could happen during procedure.Then per the event, 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 has been verified.An internal corrective action has been opened to address the pebax damages.

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4922690
• MDR Text Key: 22512907
• Report Number: 9673241-2015-00459
• 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
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 17024450M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2014
• 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