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

Model Number H74939185401510

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).The returned product consisted of a coyote balloon catheter in two pieces.The balloon was loosely folded with blood in the inflation lumen and balloon.The shaft, hypotube, and bonds were microscopically and visually examined.The shaft is completely separated 111.6cm from the hub.The fractured/separated ends of the shaft were stretched and jagged which indicates the shaft separation was due to tensile forces.There are numerous hypotube and shaft kinks.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

It was reported that removal difficulties were encountered and shaft break occurred.Vascular access was obtained via ipsilateral antegrade approach.The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery (sfa).After a 6f non-bsc introducer sheath was advanced, a non-bsc guide wire was advanced but failed to cross along with another non-bsc guidewire.After a 9x40mm non-bsc guide wire was used at the proximal-cap, a truepath cto device successfully crossed the lesion.Body surface echo and intravascular ultrasound were used to visualize the lesion.The non-bsc introducer sheath did not completely enter in the sfa.When trying to advanced a 4.0mm x 150mm x 150cm mr coyote¿ balloon catheter, the shaft got bent in the descending femoral artery.Without checking the bending of the shaft, the device was advanced into the lesion as it was and dilation was performed.Following dilation, the device could not be removed.Excessive force was applied and the hypotube got separated.The device was completely removed using a snare.A 4x4mm non-bsc balloon was advanced and dilated the lesion.A 6x15cm innova stent was deployed in the distal sfa and a 6x15cm non-bsc stent was deployed in the proximal sfa.Post dilation was performed using a non-bsc balloon and the procedure was completed.The physician stated that inflation and deflation of the coyote¿ balloon catheter was performed without issue.No further patient complications were reported and the patient's status was stable.

• Brand Name: COYOTE¿
• 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: 7105507
• MDR Text Key: 94472366
• Report Number: 2134265-2017-11747
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K111295
• 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: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: H74939185401510
• Device Catalogue Number: 39185-40151
• Device Lot Number: 21041473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2017
• 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
• Patient Outcome(s): Required Intervention