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

Model Number H74939135152010

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that shaft break occurred.The patient underwent an endovascular treatment.Vascular access was obtained utilizing ipsilateral approach.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified anterior tibial artery.After a non-bsc introducer sheath was engaged and a non-bsc guidewire crossed the lesion, a 1.5mm x 20mm x 143cm coyote¿ es balloon catheter was advanced for dilation.After dilation was performed, the device was removed.However, during removal, both the device and the non-bsc guidewire were detached.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Ae or product problem updated and corrected from product problem to reported issue is both an adverse event and product problem.Type of reportable event updated and corrected from malfunction to serious injury.Device evaluated by mfr: returned product consisted of a coyote es balloon catheter in two pieces.The shaft, balloon and tip were microscopically examined.There was contrast in the inflation lumen and blood in the inflation lumen, guidewire lumen and balloon.The balloon was loosely folded.Microscopic examination of the revealed that the shaft was torn and stretched 19cm - 21.5cm distal of the exit notch and detached 21.5cm from the exit notch.The proximal end of the distal separation was also torn, kinked and damaged.The tip was damaged.Due to the condition of the returned device, it was not possible to inflate the balloon; however, the balloon was microscopically inspected and no damage or irregularities were identified.Inspection of the remainder of the device 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 further reported that catheter removal difficulties were encountered.The physician pulled the device forcefully and it was detached at the balloon-shaft junction.The detached parts were completely removed from the patient's body with a snaring device.Additional dilatation was performed with a non-bsc balloon catheter.

• 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: 6573218
• MDR Text Key: 75422147
• Report Number: 2134265-2017-04884
• 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: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: H74939135152010
• Device Catalogue Number: 39135-15201
• Device Lot Number: 0019258695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2016
• 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