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

Model Number H74939135202010

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Returned product consisted of a coyote es balloon catheter in two pieces.The balloon was loosely folded with blood in the inflation lumen and balloon.The tip is damaged.The hypotube is completely separated 11cm from the hub.Functional testing using an inflation device was used to inflate the balloon and revealed a pinhole in the balloon 4mm from the proximal markerband.There were numerous hypotube and shaft kinks.Inspection of the remainder of the device presented no other damage or irregularities.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 & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on 01dec2017.It was reported that crossing difficulties were encountered.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel below the knee.A 2mm x 20mm x 143cm coyote¿ es balloon catheter was advanced for dilatation.However, the device was unable to cross the lesion.The procedure was completed with a different device.No patient complications nor injuries were reported.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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7126085
• MDR Text Key: 95533712
• Report Number: 2134265-2017-12414
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2020
• Device Model Number: H74939135202010
• Device Catalogue Number: 39135-20201
• Device Lot Number: 21157389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• 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