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

Model Number H74939135202010

Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

Patient age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.: returned product consisted of coyote es balloon catheter.There was blood and contrast in the inflation lumen and balloon.The shaft was stretched and separated 23cm from the distal tip.The shaft at the guidewire exit notch was torn and stretched.There were numerous shaft and hypotube kinks.Magnified inspection of the balloon, proximal bond and markerbands did not reveal any damage.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 most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel in the left leg.A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, on the first inflation at 5 atmospheres for 10 seconds, the balloon ruptured.The device was completely removed from the patient's body and the procedure was completed with another coyote balloon catheter.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of coyote es balloon catheter.There was blood and contrast in the inflation lumen and balloon.The shaft was stretched and separated 23cm from the distal tip.The shaft at the guidewire exit notch was torn and stretched.There were numerous shaft and hypotube kinks.Magnified inspection of the balloon, proximal bond and markerbands did not reveal any damage.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 most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel in the left leg.A 2mm x 20mm x 143cm coyote¿ es balloon catheter was advanced for dilatation.However, on the first inflation at 5 atmospheres for 10 seconds, the balloon ruptured.The device was completely removed from the patient's body and the procedure was completed with another coyote balloon catheter.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Age at time of event: late 50s.(b)(4).

Event Description

It was further reported that the target lesion was located in the superficial femoral artery with a reference vessel diameter of 5mm.When the ruptured balloon was removed at the distal tip of the sheath, resistance was encountered and the device was strongly pulled.However, it was noted that the shaft was separated and was remained on the wire.All devices were removed together with the wire but the wire style was deformed to "z type".

• 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: 5728732
• MDR Text Key: 47496948
• Report Number: 2134265-2016-05259
• 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,Followup
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2017
• Device Model Number: H74939135202010
• Device Catalogue Number: 39135-20201
• Device Lot Number: 16838915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2014
• 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: INFLATION DEVICE:EVEREST