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

Model Number H74939135204010

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product. (b)(4).Device evaluated by mfr: returned device consisted of a coyote es balloon catheter with a stopcock.The distal end of the device (tip, balloon, markerbands, and distal shaft) was not returned for analysis.The hypotube and proximal shaft were tactile and microscopically inspected.Inspection revealed numerous kinks in the hypotube, with a complete separation in the proximal shaft.The separated end appeared to have had excessive tensile force applied to it.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Functional testing could not be done, due to the condition of the returned device.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

It was reported that shaft break and catheter entrapment occurred.After a non-bsc guidewire crossed the lesion, a 2mm x 40mm x 145cm coyote es balloon catheter was attempted to be advanced over the guide wire to dilate the lesion.However, the device became stuck with the wire outside the patient and when the physician forcefully pulled the device out, the balloon shaft got broken.The procedure was completed with a non-bsc balloon catheter.No patient complications were reported and the patient's status was good.

• 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: 5976357
• MDR Text Key: 55572714
• Report Number: 2134265-2016-08464
• 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
• Type of Report: Initial
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: H74939135204010
• Device Catalogue Number: 39135-20401
• Device Lot Number: 19220845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2016
• 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
• Treatment: GUIDEWIRE:CHEVALIER UNIVERSAL CH; INTRODUCER SHEATH:TERUMO6F