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

Model Number H74939135152010

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the return product consisted of a coytoe es balloon catheter.The balloon, tip, shafts, hypotube, and bonds were microscopically and visually examined.There was contrast and blood in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded.There were numerous kinks throughout the shaft and hypotube.Microscopic examination of the shaft revealed a 1mm hole 10 mm from the distal portion of distal tip marker band.The hole in the shaft was consistent with a guidewire puncture though the shaft.The tip of the device was damaged.There were no irregularities in the balloon or marker band material that could have contributed to the damage.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 cause of the reported difficulties may be due interaction with another device.(b)(4).

Event Description

Reportable based on device analysis completed on 10-may-2017.It was reported that crossing difficulties were encountered.The chronic totally occluded (cto) target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).After a guidewire crossed the lesion for 20 cm, a 1.5 mm x 20 mm x 143 cm coyote¿ es balloon catheter was advanced but failed to cross the lesion.The device was removed and the procedure was completed with another coyote balloon catheter.No patient complications were reported and patient's status was good.However, returned device analysis revealed a shaft hole.

• 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: 6596328
• MDR Text Key: 76157770
• Report Number: 2134265-2017-05415
• 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: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: H74939135152010
• Device Catalogue Number: 39135-15201
• Device Lot Number: 19917898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• 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