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

Model Number	24701
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel in the upper limb.A 2mm x 30mm x 143cm coyote es balloon was advanced for dilation.However, while the physician inflated the balloon, before it reaches the nominal pressure, the balloon broke.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel in the upper limb.A 2mm x 30mm x 143cm coyote es balloon was advanced for dilation.However, while the physician inflated the balloon, before it reaches the nominal pressure, the balloon broke.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.It was further reported that the 80% stenosed target lesion was located in the non-tortuous and moderately calcified pedial artery.The balloon ruptured during the first inflation at 3 atmospheres and was completely removed from the patient.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The balloon was 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 there is a balloon pinhole at the proximal markerband.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel in the upper limb.A 2mm x 30mm x 143cm coyote es balloon was advanced for dilation.However, while the physician inflated the balloon, before it reaches the nominal pressure, the balloon broke.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.It was further reported that the 80% stenosed target lesion was located in the non-tortuous and moderately calcified pedial artery.The balloon ruptured during the first inflation at 3 atmospheres and was completely removed from the patient.

• Brand Name: COYOTE ES
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8566711
• Report Number: 2134265-2019-04559
• Device Sequence Number: 11520511
• Product Code: LIT
• UDI-Device Identifier: 08714729767343
• UDI-Public: 08714729767343
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2019

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: 09/21/2020
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0022691584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/02/2019; 06/11/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/23/2019; 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1