MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939135152010

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of coyote es balloon catheter.The balloon was loosely folded.There was blood in the inflation lumen and wire lumen.The outer shaft, inner shaft, balloon and tip were microscopically examined.There was a pinhole in the balloon material at the markerband.Microscopic examination of the balloon presented no irregularities in the balloon material or markerbands that could have contributed to the damage.There were numerous hypotube kinks.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 13-aug-2015.It was reported that crossing difficulties were encountered.The chronic totally occluded (cto) target lesion was located in the bilateral iliac arteries.After a guide wire crossed the lesion, a 1.5mmx20mmx143cm coyote¿ es balloon catheter was advanced but failed to cross the lesion.The device was removed and the procedure was completed with a coyote fc balloon catheter.No patient complications were reported and the patient¿s status was good.However, returned device analysis revealed a balloon pinhole.

• Brand Name: COYOTE¿ ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5063689
• MDR Text Key: 25225545
• Report Number: 2134265-2015-05921
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K080982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Report Date: 08/13/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: H74939135152010
• Device Catalogue Number: 39135-15201
• Device Lot Number: 17611384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2015
• 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