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

Model Number 24691

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr: the device was returned for analysis.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.There are numerous hypotube and shaft kinks.Microscopic examination of the device presented that a portion of the outer shaft was plastically deformed 9.8cm from the tip which also has a 2mm longitudinal tear.The balloon is intact and has no damage.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The inner shaft is buckled in numerous locations.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported difficulty, which could not be confirmed because the clinical circumstances could not be replicated.

Event Description

Reportable based on device analysis completed on 17 mar 2019.It was reported that crossing difficulties were encountered.The target lesion was located in a vessel below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced but failed to cross the lesion.The procedure was completed with a different device.No patient serious injury nor adverse event were reported.However, returned device analysis revealed a shaft hole.

• Brand Name: COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8465410
• MDR Text Key: 140443017
• Report Number: 2134265-2019-03227
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767169
• UDI-Public: 08714729767169
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2021
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 23056304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1