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

Model Number	24704
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.The returned complaint device consisted of a coyote balloon catheter.The balloon is loosely folded with blood in the inflation lumen and balloon.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Microscopic examination of the device revealed that the balloon has a pinhole 79mm from the proximal markerband.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on analysis completed on 05 apr 2019.It was reported that a balloon failed to inflate.A percutaneous coronary intervention was being performed on a 60% stenosed, severely calcified and mildly tortuous lesion.The 2mm x 100mm x 150cm coyote balloon was positioned at the lesion and inflated but lost pressure at 3-4 atmospheres.The procedure was successfully completed with a different device without issue or patient injury.However, returned device analysis revealed a pin hole.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8536898
• Report Number: 2134265-2019-04105
• Device Sequence Number: 16243328
• Product Code: DQY
• UDI-Device Identifier: 08714729797135
• UDI-Public: 08714729797135
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

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: 03/12/2021
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0021853585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1