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

Model Number D-1197-16-S

Device Problems Bent (1059); Break (1069); Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a procedure, the catheter could not apperceive magnetic signal.The case was completed by changing the catheter without any patient consequence.Upon receiving the product in biosense webster lab on (b)(4) 2014, it was noticed that peek housing bent and broken between ring #1 proximal side and ring #2 distal side with internal parts exposed, making this event reportable.Investigation is still in progress.A supplemental report on device evaluation will be submitted.

Manufacturer Narrative

(b)(4) it was reported that during the procedure, the catheter could not apperceive magnetic signal.The returned device was visually inspected upon receipt and the tip dome was damaged.Peek housing was bent and broken between ring #1 proximal side and ring #2 with internal parts exposed right next to distal side of electrode.A scanning electron microscope testing was performed over the damaged area.The results showed that the peek housing presented evidence of elongations, which might have been caused due to an external excessive force applied.No other anomalies were observed during sem analysis.However, it remains unknown how the peek housing was broken.Some follow up questions were made to the affiliate in order to get additional information but he/she never replied back.Then per the reported event, the catheter was tested per the reported event on eeprom, carto 3 and coil disconnection tester (cdt) and catheter failed the cdt and carto 3.Error 105 was observed.The catheter was then dissected and it was determined that the potential root cause was a failure of the sensor inside the epoxy due to the external damage.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.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.The reported customer complaint has been verified.However, for the peek housing condition it remains unknown how it was broken.

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 4425578
• MDR Text Key: 21848206
• Report Number: 9673241-2015-00027
• 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: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: D-1197-16-S
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 17027113M
• Other Device ID Number: (01)10846835000559
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1