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

Model Number H74939135204010

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Returned product consisted of a coyote es balloon catheter in five pieces.The distal shaft, balloon, markerbands and tip were not returned for analysis.The shaft, hypotube, and bonds were microscopically and visually examined.The hypotube is separated 67.4cm from the hub.The device is so damaged it cannot be determined which separated hypotube fractured ends go together.There is a 20cm hypotube section, a 10.8cm hypotube section and a 3.5cm hypotube section.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.The distal outer shaft is separated and the distal portion of the shaft, balloon, markerbands and tip were not returned.The shaft could not be measured due to the numerous kinks and stretching.The fractured/separated end of the distal shaft is stretched and jagged which indicates the shaft separation was due to tensile forces.There are numerous hypotube and shaft kinks.The shaft is stretched in numerous locations.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

Event Description

Same case as mdr id: 2134265-2018-00533.Reportable based on device analysis completed on 28-feb-2018.It was reported that crossing difficulties and shaft damage were occurred.Vascular access was obtained utilizing a contralateral approach.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified iliac vessel.A 2mm x 40mm x 145cm coyote¿ es balloon catheter was advanced but failed to cross the lesion and it was noted that the shaft part got crumpled.Another 2mmx40mmx145cm coyote¿ es balloon catheter was advanced again for dilatation.However, upon delivering, the device became stuck and could not be removed.The physician then attempted to pull the device and the shaft detached.The device was surgically removed.No further patient complications were reported and the patient's status was good.However, returned device analysis revealed hypotube broken, shaft broken and balloon detached.It was further reported that the separation occurred outside the patient's body.

• 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: 7370276
• MDR Text Key: 103683021
• Report Number: 2134265-2018-02042
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2018

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: 11/30/2019
• Device Model Number: H74939135204010
• Device Catalogue Number: 39135-20401
• Device Lot Number: 19916363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• 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