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

Model Number H74939135402010

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that shaft break occurred.Vascular access was obtained bidirectionally with anterograde approach.The 99% stenosed, 17cm long target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).After a guidewire crossed the lesion, a 4x20 sterling balloon catheter was advanced for pre-dilatation.A 4mmx20mmx144cm coyote¿ es balloon catheter was advanced for post dilation.However, during procedure, the shaft broke and remained on the guide wire.The balloon was withdrawn together with the guidewire with no remnant found inside the patient and the procedure was completed.No patient complications were reported and the patient's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 lumen.The balloon was loosely folded.There was damage (twisted) to the port/exit notch.Microscopic and tactile inspection revealed numerous kinks in the hypotube.The outer shaft was separated 35cm from the tip of the device.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 shaft break occurred.Vascular access was obtained bidirectionally with anterograde approach.The 99% stenosed, 17cm long target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).After a guidewire crossed the lesion, a 4x20 sterling balloon catheter was advanced for pre-dilatation.A 4mmx20mmx144cm coyote es balloon catheter was advanced for post dilation.However, during procedure, the shaft broke and remained on the guide wire.The balloon was withdrawn together with the guidewire with no remnant found inside the patient and the procedure was completed.No patient complications were reported and the patient's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: 5500858
• MDR Text Key: 40342901
• Report Number: 2134265-2016-01597
• 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: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2017
• Device Model Number: H74939135402010
• Device Catalogue Number: 39135-40201
• Device Lot Number: 17018931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2014
• 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: 83 YR
• Patient Weight: 42