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

Model Number	24704
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified posterior tibial artery.A 3.0mm x 80mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the second inflation at 11 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned complaint device consisted of a coyote balloon catheter.The balloon is loosely folded.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Functional testing was carried out by attaching an inflation device filled with water to the hub of the complaint device and inflating the device to rated burst pressure (rbp).The device inflated and held pressure for 5 minutes without leaking.Inspection of the device presented no damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified posterior tibial artery.A 3.0mm x 80mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the second inflation at 11 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• 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: 10181556
• Report Number: 2134265-2020-08338
• Device Sequence Number: 19603391
• Product Code: DQY
• UDI-Device Identifier: 08714729796541
• UDI-Public: 08714729796541
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• 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): 08/04/2020

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: 03/31/2023
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0025427312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR