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

Model Number H74939135204010

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2018

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 in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube is completely separated 87.7cm from the hub.The fracture faces were oval as if kinked prior to separation.The damage is consistent with damage seen with the use of a sheath.There is shaft damage at the exit notch that is consistent with damage seen with the use of a guide wire.There are numerous hypotube and shaft kinks.The tip is damaged.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

It was reported that shaft break occurred.Vascular access was obtained utilizing ipsilateral antegrade approach with a 4.5fr non-bsc introducer sheath via left femoral artery.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified peroneal artery and posterior tibial artery.A non-bsc guide wire was advanced and crossed the lesion.After a non-bsc balloon catheter was inserted, the physician attempted to perform kissing balloon technique and a 2mm x 40mm x 145cm coyote¿ es balloon catheter was advanced into the same sheath.However, it was noted that the coyote balloon catheter got stuck in the sheath and it could not be removed.The catheter balloon was pulled to be removed from the sheath but the shaft got detached.The device was completely removed and the procedure was completed with a non-bsc balloon catheter.No patient complications nor injuries 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: 7571132
• MDR Text Key: 110137890
• Report Number: 2134265-2018-04760
• 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: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2020
• Device Model Number: H74939135204010
• Device Catalogue Number: 39135-20401
• Device Lot Number: 0021169895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2017
• 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
• Treatment: BALLOON CATHETER: IKAZUCHI PAD; GUIDEWIRE: CRUISE ETC; INTRODUCER SHEATH: PARENT 4.5FR