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

Model Number H74939135304010

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that shaft break occurred.A 3mm x 40mm x 146cm coyote es balloon catheter was advanced but would not go further.Upon removal, the catheter broke somewhere on the femoral artery and so the balloon tip and balloon itself was left inside the patient.The device was then removed surgically.No patient complications were reported and the patient's status was fine and okay.

Manufacturer Narrative

Device evaluated by manufacturer: returned device consisted of a coyote es balloon catheter.The balloon was tightly folded with blood and contrast in the hub and lumen, with blood on the balloon.Microscopic inspection of the balloon and markerband found no irregularities or defects.Microscopic inspection found no irregularities with the bond of the device.Microscopic inspection of the tip found no irregularities or defects.Microscopic and tactile inspection revealed numerous kinks in the hypotube and distal shaft.There was a separation in the hypotube 92cm from the strain relief.The fracture faces were oval, suggesting the area was kinked prior to separating.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.A 3mm x 40mm x 146cm coyote es balloon catheter was advanced but would not go further.Upon removal, the catheter broke somewhere on the femoral artery and so the balloon tip and balloon itself was left inside the patient.The device was then removed surgically.No patient complications were reported and the patient's status was fine and okay.

• 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: 5610054
• MDR Text Key: 43712954
• Report Number: 2134265-2016-03240
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: H74939135304010
• Device Catalogue Number: 39135-30401
• Device Lot Number: 18170249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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
• Patient Outcome(s): Required Intervention