MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OFFROAD; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	39537
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The micro catheter was received in two sections, due to a break in the shaft.The break was located at approximately 40mm distal of the hub.Both sections of the shaft were kinked at various locations along its length.Both sections of the micro catheter were received loaded on to the customers guidewire.A visual and microscopic examination identified no issues with the balloon catheter.No other issues were noted with the returned device.
Event or Problem Description
Reportable based on device analysis completed on 14mar2019.It was reported that the device was kinked and had difficulty advancing.The target lesion was located in superior femoral artery.An offroad was selected for use.During the procedure, the re-entry location was identified and the balloon was positioned within the distal part of the lesion.The balloon was inflated to two and a half atmospheres.Subsequently, the zipwire was removed from the postioning balloon and replaces with a thruway guidewire.It was difficult to advance the microlancet over the wire inside the balloon catheter and became significantly kinked.The microlancet failed to advance further.The devices were removed.The procedure was not completed as re-entry of the lesion was unable to occur.No patient complications were reported.Another attempt to cross the total occlusion was to be planned in the future.However, device analysis revealed that the device was broken 40cm distal from the hub.It was further reported that the break likely occurred during the procedure when the lancet would not advance.

• Brand Name: OFFROAD
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8478294
• Report Number: 2134265-2019-03385
• Device Sequence Number: 1253335
• Product Code: PDU
• UDI-Device Identifier: 08714729798729
• UDI-Public: 08714729798729
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K131914
• 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
• Report Date (Section B): 04/03/2019

1 Device was Involved in the Event

1 Patient 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: 02/28/2021
• Device Model Number: 39537
• Device Catalogue Number: 39537
• Device Lot Number: 22224880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR