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

Model Number D-1347-02-S

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2015

Event Type  malfunction  

Manufacturer Narrative

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 smart touch electrophysiology catheter approved under (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch unidirectional sf catheter.The surgeon noticed a white deposit and visible damage on the distal tip of the catheter after he started the intervention.They used another device to finish the intervention.There was no patient consequence.Since the foreign material and the visible damage to the catheter is within the usable length of the catheter, this event is assessed as a reportable malfunction.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 9/10/15.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).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch unidirectional sf catheter.The surgeon noticed a white deposit and visible damage on the distal tip of the catheter after he started the intervention.They used another device to finish the intervention.There was no patient consequence.Upon receipt, the catheter was visually inspected and a clear like material was found on the distal tip dome.A ft-ir test was performed in order to identify the type of foreign material.The results demonstrated that the particle had a biological composition similar to that shown by human tissue.After removing the foreign material from the tip section in order to perform ft-ir testing, the catheter was reviewed and it was found in good condition.All rings were free of damage.No bends or sharp edges were observed.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 regarding a foreign particle has been verified.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV 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: 5032164
• MDR Text Key: 25823894
• Report Number: 9673241-2015-00565
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/04/2015

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-1347-02-S
• Device Catalogue Number: D134702
• Device Lot Number: 17145446L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1