MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1327-05-S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigational analysis has been completed.The returned device was visually inspected and found that the clear sensor sleeve (pebax) had reddish material inside of it.The pebax was sent to the spectrum electro magnetic (sem) laboratory to perform an analysis to confirm possible fracture or holes in the pebax.The results are as follows.The sem results show that the external surface exhibit no evidence of scratches, pinholes and/or damages.An internal corrective action has been opened to investigate the pebax damage.Also, the shaft was found broken 9.5 cm from the dome.Expose wires and reddish material were observed on the fracture.An internal corrective action has been opened to investigate the thermocool smart touch broken shaft issue.Per the event, a deflection test was performed and the catheter passed.The device history record (dhr) was reviewed and no anomalies were found.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint cannot be confirmed.Internal corrective actions have been opened to investigate the pebax damage and the thermocool smart touch broken shaft issue.

Event Description

It was reported that a patient underwent a procedure with a smart touch bidirectional catheter, and the biosense webster failure analysis lab noted during analysis that the shaft was broken.Originally it was reported that during the procedure, the curvature of the probe was broken.The catheter was changed to complete the procedure.There was no patient consequence.Since the catheter is unable to deflect or relax completely, the user will not be able to use the device and will have to replace it.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.The bwi failure analysis lab noted the returned catheter condition of the clear sensor sleeve had reddish material inside of it.No damage was found on the sleeve.This issue was assessed as not reportable.The foreign material was found underneath the pebax.However, there is no damage to the pebax integrity that could cause the foreign material to travel into the blood circulation.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.In addition, during analysis on august 10, 2015, it was identified that the shaft was broken at a distance of 9.5 cm from the dome.It is unclear when this damage to the shaft occurred.Therefore to be conservative, since the broken shaft is within the usable length of the catheter, we are assessing this issue as reportable.The awareness date is august 10, 2015.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 5037830
• MDR Text Key: 25784973
• Report Number: 9673241-2015-00570
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 05/13/2015

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: 02/29/2016
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17194428M
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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