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 No Display/Image (1183); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch¿ uni-directional navigation catheter and magnetic signal was not observed.There was no patient consequence.During procedure, catheter did displayed magnetic signal.The procedure was completed successfully by exchanging the catheter.This event was originally considered non-reportable, however, bwi became aware of the product returned condition: clear sensor sleeve (pebax) is torn and has a small surface cut on proximal side of ring # 1 on january 20, 2015 and have reassessed the complaint as reportable.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on january 20, 2015.The analysis has begun but is not completed at this time.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smarttouch® uni-directional navigation catheter approved under 510(k) p030031/ pma # s053.(b)(6).(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an atrial fibrillation procedure with a thermocool smarttouch uni-directional navigation catheter and magnetic signal was not observed.There was no patient consequence.During procedure, catheter did displayed magnetic signal.The procedure was completed successfully by exchanging the catheter.This event was originally considered non-reportable, however, bwi became aware of the product returned condition: clear sensor sleeve (pebax) is torn and has a small surface cut on proximal side of ring # 1 on (b)(6) 2015 and have reassessed the complaint as reportable.The bwi failure analysis lab received the device for evaluation.The returned device was visually inspected upon receipt and reddish brown material similar to human blood was found on the proximal side of ring #1.Further examination revealed that pebax was torn and with a small surface cut on the proximal side of ring #1.This type of pebax damage is further investigated under an internal corrective action.All the catheters are inspected for visual damages before packaging.During manufacturing process on line inspections are in place to prevent damage pebax from leaving the facility.Then per the reported magnetic signal issues, the catheter was evaluated for carto 3 and it was recognized by the system, no error messages were displayed and the catheter was properly visualized.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 was not confirmed.Management is notified of failure analysis results using monthly complaint trend reporting.An internal corrective action was created to address the pebax issues on smart touch.

• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4512405
• MDR Text Key: 5404401
• Report Number: 9673241-2015-00078
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2014

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: 01/31/2015
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 16057708M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/25/2014
• Initial Date FDA Received: 02/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• 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