MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR® THERMOCOOL®; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1197-16-S

Device Problems Bent (1059); Crack (1135); Failure to Read Input Signal (1581)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

It was reported that during this procedure, the navistar thermocool catheter could not apperceive magnetic signal on the carto 3 system.The catheter was exchanged.The procedure was completed and there was no patient injury reported.The initial reported complaint itself was not indicative of a reportable event.Upon visual inspection of the returned complaint catheter on april 30, 2014, the bwi failure analysis lab noted that the peek housing was bent and cracked open between electrode rings #1 and #2 leaving internal parts exposed.This condition was not reported by the customer.The returned catheter condition is indicative of a reportable event, thus marking april 30, 2014 as the awareness date for this report.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during this procedure, the navistar thermocool catheter could not apperceive magnetic signal on the carto 3 system.The catheter was exchanged.The procedure was completed and there was no patient injury reported.Upon visual inspection of the returned complaint catheter, it was noted that the peek housing was bent and cracked open between electrode rings #1 and #2 leaving internal parts exposed.This condition was not reported by the customer.The returned catheter condition was indicative of a reportable event.The device was tested and it passed eeprom data test, however re-calibration test could not be performed due to the catheter tip damaged condition.Also, an electrical test was performed and the catheter failed, no readings were observed on electrode #1 due to a cracked condition presented on the peek housing.Based on the continuity test, no damage or defect was found with the wiring, sensor coils, soldering, or shorts.This concludes that the failure is related to the pcb board malfunction.The catheter was sent to sem (scanning electron microscope) analysis to determine the cause of the fracture on the peek housing and results showed that the sample received presented evidence elongations and stress marks were also observed.The rest of the peek housing presented evidence of fatigue.The elongations found suggested that the sample was pulled off until rupture.No other anomalies were observed during analysis.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 confirmed.

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3821854
• MDR Text Key: 18071967
• Report Number: 2029046-2014-00145
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031
• 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: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1197-16-S
• Device Catalogue Number: NI75TCDH
• Device Lot Number: UNKNOWN_D-1197-16-S IRW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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