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

Model Number D-1260-04-S

Device Problems Break (1069); Charred (1086); Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

It was reported during an atrial flutter (afl) procedure, the puller wire broke on this catheter.The case was completed without any patient consequences.Upon receiving the product in biosense webster lab on (b)(6) 2014, it was noticed that char (brownish red material) found on the distal end of tip and 2 mm from tip and electrode #1 there is also char (brownish red material), making this event reportable.Investigation is still in progress.A supplemental report on device evaluation will be submitted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) it was reported during an atrial flutter (afl) procedure, the puller wire broke on this catheter.The case was completed without any patient consequences.Upon receiving the product in biosense webster lab on november 19th 2014, it was noticed that char (brownish red material) found on the distal end of tip and 2 mm from tip and electrode #1 there is also char (brownish red material), making this event reportable.The returned device was visually inspected upon receipt and a brownish reddish material was found on the distal end of tip and electrode #1.However the material was lost during the decontamination process.Per the complaint, the catheter was tested for deflection and the catheter failed.Afterwards, the catheter was dissected and the puller wire was found broken at the tips section, causing the deflection issue.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 verified.However the root cause of the brownish reddish material remains unknown.

• 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 ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4330399
• MDR Text Key: 16990960
• Report Number: 9673241-2014-00566
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010068/S6
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: D-1260-04-S
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 17078714M
• Other Device ID Number: (01)10846835003048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1