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

Model Number H74939134202010

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon rupture occurred.Vascular access was obtained utilizing an ipsilateral antegrade approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.After a guide wire crossed the lesion, a 2mmx20mmx142cm coyote¿ es balloon catheter was advanced for dilation.However, on the first inflation at 5 atmospheres, the balloon ruptured after being inflated for 5 seconds.The device was removed from the patient's body.The procedure was completed with another coyote nc balloon catheter.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: returned device consisted of a coyote es balloon catheter with blood in the balloon and air lumen.The balloon was loosely folded.Functional testing was performed by connecting an inflation device filled with water to the hub.When pressure was applied, water was found to be leaking from the balloon.Microscopic examination found a pinhole burst in the balloon material, 6 mm from the tip of the device.Microscopic inspection of the markerband, the bond and the tip found no irregularities or defects.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 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.Vascular access was obtained utilizing an ipsilateral antegrade approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.After a guide wire crossed the lesion, a 2mmx20mmx142cm coyote¿ es balloon catheter was advanced for dilation.However, on the first inflation at 5 atmospheres, the balloon ruptured after being inflated for 5 seconds.The device was removed from the patient's body.The procedure was completed with another coyote nc balloon catheter.No patient complications were reported and the patient's status was good.

• 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: 5305086
• MDR Text Key: 33705523
• Report Number: 2134265-2015-08727
• 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: 11/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: H74939134202010
• Device Catalogue Number: 39134-20201
• Device Lot Number: 18027286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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