MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) BLAZER¿ DX-20 CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	M00420SL28600
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the catheter became entangled in the patient¿s anatomy.A blazer¿ dx ablation catheter was selected for use in an atrial fibrillation ablation procedure.The catheter was introduced into the femoral vein and was being pushed up into the heart when it prolapsed on itself and then became entangled in the tricuspid valve.The physician worked to untangle the catheter from the tissue and the steering mechanism stopped working.The physician introduced a snare to dislodge the catheter from the tricuspid valve.The catheter was removed and another manufacturer¿s catheter was selected to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: visual inspection of the returned device did not reveal any defects.The steering knob and tension control knob functioned properly on both the lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Both right and left curves failed dimensional testing.The shaft was measured in three sections and was within specification.X-ray revealed multiple collapsed guide coils near the distal end of the device, which hindered movement of the steering wires to achieve the proper bend at the distal end.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion for the guide coil collapse is design specification as the device problem was traced back to the design specifications.Updated: device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes.(b)(4).
Event or Problem Description
It was reported the catheter became entangled in the patient¿s anatomy.A blazer¿ dx ablation catheter was selected for use in an atrial fibrillation ablation procedure.The catheter was introduced into the femoral vein and was being pushed up into the heart when it prolapsed on itself and then became entangled in the tricuspid valve.The physician worked to untangle the catheter from the tissue and the steering mechanism stopped working.The physician introduced a snare to dislodge the catheter from the tricuspid valve.The catheter was removed and another manufacturer¿s catheter was selected to complete the procedure.There were no patient complications.

• Brand Name: BLAZER¿ DX-20 CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7421251
• Report Number: 2134265-2018-03298
• Device Sequence Number: 61755
• Product Code: DRF
• UDI-Device Identifier: 08714729780533
• UDI-Public: 08714729780533
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K081576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2021
• Device Model Number: M00420SL28600
• Device Catalogue Number: 20SL2860
• Device Lot Number: 0021562643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No