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 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: returned product consisted of a coyote es balloon catheter.There was contrast and blood in the inflation lumen and balloon.The shaft, balloon, and tip were microscopically examined.There were numerous locations with buckling of the shaft and under the balloon.The balloon was bunched up.The distal tip was damaged.Functional testing was performed by attaching an inflation device filled with water to the device.When positive pressure was applied, a stream of water emitted from the shaft wall.The shaft was microscopically examined and a hole in the shaft wall 5.3cm distal of the exit notch was revealed.Microscopic examination presented no irregularities in the shaft material that could have contributed to the damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.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 09-nov-2016.It was reported that crossing difficulties were encountered.   the 100% stenosed target lesion was located in the moderately tortuous and severely calcified peroneal artery.A 1.5mm x 20mm x 143cm coyote¿ es balloon catheter was advanced for dilation but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, returned device analysis revealed shaft hole.

• 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: 6129102
• MDR Text Key: 60942800
• Report Number: 2134265-2016-10779
• 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: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: H74939135152010
• Device Catalogue Number: 39135-15201
• Device Lot Number: 19192415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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: JUPITER; INFLATION DEVICE: BOSTON; INTRODUCER SHEATH: MEDIKIT