MAUDE Adverse Event Report: BOSTON SCIENTIFIC COYOTE; BALLOON

Model Number COYOTE

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 07/15/2014

Event Type  malfunction  

Event Description

A 3.5 x 100mm coyote over the wire balloon used to treat a lesion in the left leg below the knee.We decided to change wires to advance the system further so an attempt to change the wires out was made.The new 0.014 wire would not insert and pass beyond the hub of the balloon.Not even the stiff side of the wire would pass.In order to save placement and get a wire down into the far side of the lesion we had to cut the hub off and we were successful at placing the new wire distal to the lesion and retrieving the balloon shaft back out of the body.

• Brand Name: COYOTE
• Type of Device: BALLOON
• Manufacturer (Section D): BOSTON SCIENTIFIC; maple grove 55311
• MDR Report Key: 3952632
• MDR Text Key: 4643030
• Report Number: MW5037351
• Device Sequence Number: 1
• Product Code: LIT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2014

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: 06/01/2015
• Device Model Number: COYOTE
• Device Catalogue Number: H74939186351010
• Device Lot Number: 15289832
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: 6 FR ANSEL 1; 300CM CONFIENTA PRO 12; 300CM SPARTACORE
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 93