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	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the pulmonary artery.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, when the balloon was inflated at 12 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the pulmonary artery.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, when the balloon was inflated at 12 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Age of time of event: 18yrs or older.Initial reporter facility name: (b)(6).Device evaluated by mfr.: returned product consisted of a coyote es 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 at the distal markerband.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8578201
• Report Number: 2134265-2019-04751
• Device Sequence Number: 13886027
• Product Code: LIT
• UDI-Device Identifier: 08714729767381
• UDI-Public: 08714729767381
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 06/04/2019

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: 05/15/2019
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0020643198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 60