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

Model Number H74939135404010

Device Problem Failure to Advance (2524)

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

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) device evaluated by mfr: returned product consisted of a coyote es balloon catheter with no other devices.There was blood and contrast in the inflation lumen and balloon.The tip and balloon were examined.The balloon was loosely folded.The tip was damaged.There was a tear in the inner and outer shaft material at the guide wire exit notch which extended 8 cm distally.The damage is consistent with the guide wire tearing through the shaft.There were numerous hypotube kinks.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.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

Reportable based on device analysis completed on 08-sep-2016.It was reported that crossing difficulties were encountered.The 95% target lesion was located in the moderately tortuous and moderately calcified vessel below the knee.A 4mmx40mmx146cm coyote es balloon catheter was advanced but failed to cross the lesion.The procedure was completed with a peripheral cutting balloon (pcb).No patient complications were reported and the patient's status was good.However, returned device analysis revealed a shaft hole/ perforation.

• 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: 5992469
• MDR Text Key: 56491854
• Report Number: 2134265-2016-08645
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2017
• Device Model Number: H74939135404010
• Device Catalogue Number: 39135-40401
• Device Lot Number: 16965891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2014
• 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: GUIDEWIRE: COMMED; INFLATION DEVICE: KANEKA; INTRODUCER SHEATH:PARENT