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

Model Number H74939135404010

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Returned product consisted of the hypotube and shaft of a coyote es balloon catheter in two pieces, the hub not received.The shaft, hypotube, and bonds were microscopically and visually examined.There is tip damage.The shaft was completely separated 26.5cm from the tip.As the shaft is completely circumferentially torn it is consistent with the reported damage.There are numerous hypotube and shaft kinks.There is no evidence that the device failed to meet applicable product specifications prior to shipment.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that shaft break occurred.The target lesion was located in the tibial artery.A 4mmx40mmx146cm coyote¿ es balloon catheter was advanced for dilation.However during procedure, the balloon broke with a "c" tear.No patient complications were reported.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6945224
• MDR Text Key: 90302997
• Report Number: 2134265-2017-10098
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: H74939135404010
• Device Catalogue Number: 39135-40401
• Device Lot Number: 09/25/2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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