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

Model Number D-1336-01-S

Device Problems Break (1069); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch unidirectional catheter.During the bwi failure analysis visual inspection, it was found that the shaft was broken at 90 mm from the dome and internal components were exposed.During the procedure, the catheter stopped deflecting properly.At this time, the physician chose to finish the procedure when the issue occurred.The procedure was completed without patient consequence.This reported issue was assessed as not reportable.This event is being reported because on (b)(6), 2015 the bwi failure analysis lab received the device for evaluation and found that the shaft was broken at 90 mm from the dome and internal components were exposed.Upon request, additional information was received on this returned catheter condition.The catheter was not withdrawn from the patient with difficulty that may have caused this condition.This condition was not noted prior to use of the catheter, during withdrawal or upon sending the product back to the bwi failure analysis lab.The 8.5 sl0 sheath was used.The catheter was not pre-shaped.It was confirmed that there was no patient consequence.This event was originally considered non-reportable, however, bwi became aware the shaft was broken and internal components were exposed on (b)(6) 2015 and have reassessed the event as reportable.The awareness date for this record is (b)(6) 2015.

Manufacturer Narrative

(b)(4).The returned device was visually inspected upon receipt and it was found that shaft was broken at 90 mm from the dome with internal components exposed.This condition was not originally reported by the customer however an internal investigation is being held.Due to the exposed components, an electrical test was performed and catheter passed.Therefore, we can conclude all the electrical wires were perfectly insulated.During manufacturing all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.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 cannot be confirmed.An internal corrective action has been opened to investigate the thermocool smart touch broken shaft issue.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: shahe garabedian ; 15715 arrow hwy; irwindale, CA 91706 ; 9098397362
• MDR Report Key: 4718168
• MDR Text Key: 5745959
• Report Number: 2029046-2015-00102
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: D-1336-01-S
• Device Catalogue Number: D133601
• Device Lot Number: 17058526M
• Other Device ID Number: (01)10846835008982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2014
• 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