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

Model Number H74939135152010

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon and tip detachment occurred and catheter withdrawal difficulties were encountered.Vascular access was obtained utilizing contralateral approach.The 100%, chronic total occlusion (cto), 20cm in length target lesion was located in the moderately tortuous and severely calcified right superficial femoral artery.After a several guidewires with micro catheter attempted to pass through the cto but failed to cross the lesion, the wire was exchanged to a 30g non-bsc guidewire and it reached into about 10 cm of the lesion but the micro catheter was unable to be advanced via the guidewire.A 1.5mmx20mmx143cm coyote¿ es balloon catheter was advanced about 5cm and inflated three times at 8 atmospheres.However, when the balloon catheter was removed, removal difficulties were encountered.When the physician pulled the device harder, it was noted that the balloon detached in the area near the monorail guide wire port and the tip part of the balloon about 23cm was still remained inside the patient.The device was removed completely using a gooseneck snare and the procedure took almost 3 and a half hours.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned device consisted of a coyote es balloon catheter with blood in the balloon, lumen and hub.The balloon was loosely folded.Microscopic inspection revealed that while the tip was not detached, it was damaged.Microscopic inspection of the balloon and markerband found no irregularities or defects.Microscopic and tactile inspection revealed numerous kinks in the hypotube and distal shaft.The outer shaft and hypotube was separated 25cm from the tip of the device, with the fracture faces were oval as if kinked prior to separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 and tip detachment occurred and catheter withdrawal difficulties were encountered.Vascular access was obtained utilizing contralateral approach.The 100%, chronic total occlusion (cto), 20cm in length target lesion was located in the moderately tortuous and severely calcified right superficial femoral artery.After a several guidewires with micro catheter attempted to pass through the cto but failed to cross the lesion, the wire was exchanged to a 30g non-bsc guidewire and it reached into about 10 cm of the lesion but the micro catheter was unable to be advanced via the guidewire.A 1.5mmx20mmx143cm coyote es balloon catheter was advanced about 5cm and inflated three times at 8 atmospheres.However, when the balloon catheter was removed, removal difficulties were encountered.When the physician pulled the device harder, it was noted that the balloon detached in the area near the monorail guide wire port and the tip part of the balloon about 23cm was still remained inside the patient.The device was removed completely using a gooseneck snare and the procedure took almost 3 and a half hours.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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5519320
• MDR Text Key: 40935597
• Report Number: 2134265-2016-02061
• 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: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: H74939135152010
• Device Catalogue Number: 39135-15201
• Device Lot Number: 18588693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• 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