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

Model Number H74939134204010

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2015

Event Type  malfunction  

Event Description

It was reported that shaft perforation occurred.The target lesion was located in the mid posterior tibial artery.A non bsc guide wire was loaded into the patient with its distal end first then a 2mm x 40mm x 144cm coyote¿ es balloon catheter was advanced over the wire into the lesion.Then the non bsc wire was removed and a 0.014 30g tip 300cm victory¿ guide wire was loaded into the back end of the balloon catheter, however, the wire exited distally outside the catheter at an area near the balloon, and not at the end of the guide wire lumen.The victory¿ guide wire then tracked down into a different vessel but no vessel dissection nor vessel perforation occurred.The victory¿ guide wire was then exchanged to a non bsc guide wire and the procedure was completed using another 2mm x 40mm x 144cm coyote¿ es balloon catheter.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of coyote es balloon catheter.There was a product mandrel in the wire lumen.The balloon was tightly folded.Microscopic examination revealed that the proximal shaft was stretched and flattened 69.5cm ¿ 79.5cm from the hub.Inspection of the remainder of the device, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that shaft perforation occurred.The target lesion was located in the mid posterior tibial artery.A non bsc guide wire was loaded into the patient with its distal end first then a 2mm x 40mm x 144cm coyote¿ es balloon catheter was advanced over the wire into the lesion.Then the non bsc wire was removed and a 0.014 30g tip 300cm victory¿ guide wire was loaded into the back end of the balloon catheter however the wire exited distally outside the catheter at an area near the balloon, and not at the end of the guide wire lumen.The victory¿ guide wire then tracked down into a different vessel but no vessel dissection nor vessel perforation occurred.The victory¿ guide wire was then exchanged to a non bsc guide wire and the procedure was completed using another 2mm x 40mm x 144cm coyote¿ es balloon catheter.No patient complications were reported and the patient's status was fine.

• 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: 4937751
• MDR Text Key: 19637729
• Report Number: 2134265-2015-04717
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2015

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: 03/12/2016
• Device Model Number: H74939134204010
• Device Catalogue Number: 39134-20401
• Device Lot Number: 16812734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2015
• Initial Date FDA Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2014
• 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
• Patient Age: 60 YR