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

Model Number H74939135254010

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon detachment occurred.The target lesion was located in the severely calcified vessel below the knee.A 2.5mm x 40mm x 146cm coyote¿ es balloon catheter was advanced to dilate the lesion.After several dilatations were performed, the device was attempted to be removed from the patient's body; however, the balloon got detached near the guidewire exit port.The detached balloon was then removed by snaring.The procedure was completed with a different device and vascular patency was observed.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of the coyote es balloon catheter in two pieces.The shafts and balloon were microscopically examined.There was blood in the inflation lumen and balloon.The balloon was loosely folded.There were numerous kinks proximal of the exit notch and throughout the distal shaft.There was a shaft separation 1mm distal of the exit notch.The inner shaft was buckled 3mm distal of the bi-component weld and in the balloon 4mm proximal of the distal markerband.The tip was damaged.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

It was reported that balloon detachment occurred.The target lesion was located in the severely calcified vessel below the knee.A 2.5mm x 40mm x 146cm coyote¿ es balloon catheter was advanced to dilate the lesion.After several dilatations were performed, the device was attempted to be removed from the patient's body; however, the balloon got detached near the guidewire exit port.The detached balloon was then removed by snaring.The procedure was completed with a different device and vascular patency was observed.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: 6613123
• MDR Text Key: 76706517
• Report Number: 2134265-2017-05558
• 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,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: H74939135254010
• Device Catalogue Number: 39135-25401
• Device Lot Number: 0020110206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2016
• 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
• Patient Outcome(s): Required Intervention