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

Model Number H74939135204010

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that balloon tear occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery (sfa).A 2mm x 40mm x 145cm coyote¿ es balloon catheter was advanced to dilate the lesion.After dilating the proximal part of sfa, the device was advanced to the distal part; however, it was noticed through fluoroscopy that the balloon part shifted from the wire.When the physician tried to pull it out, it was observed that it was torn from the tip to the middle part of the balloon.The device was completely removed from the patient and the procedure was completed with another 3.0mm coyote¿ es balloon catheter.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter with an unidentified.014 guidewire stuck in the guidewire lumen with the distal part of the guidewire protruding out of the distal shaft and balloon.The balloon was loosely folded with blood in the inflation lumen and balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.There is an inner shaft puncture hole 6mm from the proximal markerband where the guidewire is protruding through.The balloon has a 19mm longitudinal tear starting 5mm from the proximal markerband, where the guidewire is protruding through the shaft and balloon.The shaft puncture hole and balloon tear is consistent with damage seen with the use of a guidewire.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 confirmed event.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 balloon tear occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery (sfa).A 2mm x 40mm x 145cm coyote es balloon catheter was advanced to dilate the lesion.After dilating the proximal part of sfa, the device was advanced to the distal part; however, it was noticed through fluoroscopy that the balloon part shifted from the wire.When the physician tried to pull it out, it was observed that it was torn from the tip to the middle part of the balloon.The device was completely removed from the patient and the procedure was completed with another 3.0mm coyote es balloon catheter.No patient complications were reported and the patient's status was stable.

• 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: 7582835
• MDR Text Key: 110578179
• Report Number: 2134265-2018-05047
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2020
• Device Model Number: H74939135204010
• Device Catalogue Number: 39135-20401
• Device Lot Number: 21475493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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