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

Model Number 24701

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery.A 2mm x 40mm x 144cm coyote es was advanced for pre-dilatation.However, during the first inflation at 14 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed that the tip is damaged and there is a pinhole 31mm from the tip.There is blood present in the inflation lumen, guidewire lumen, and balloon.The balloon is loosely folded.Therefore, there is no indication the device was inflated over rated burst pressure.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery.A 2mm x 40mm x 144cm coyote es was advanced for pre-dilatation.However, during the first inflation at 14 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8200359
• MDR Text Key: 131532728
• Report Number: 2134265-2018-64641
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767350
• UDI-Public: 08714729767350
• Combination Product (y/n): N
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2019
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0020691615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1