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

Model Number H74939135152010

Device Problems Detachment Of Device Component (1104); Material Rupture (1546); Device Damaged by Another Device (2915)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-05327.It was reported that balloon rupture and separation occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified basilar artery (ba).The procedure was a percutaneous transluminal angioplasty for a patient with critical limb ischemia.A 1.5mm x 20mm x 143cm coyote¿ es balloon catheter was advanced with a 6f guidezilla¿ ii pv long guide extension catheter as support for dilatation.However, upon removal, the balloon got caught in the collar of the guidezilla¿.The balloon ruptured and then detached inside of the guidezilla, and the detached portion was dislodged into the patient.The detached portion of the device remained in the patient.No patient symptoms occurred due to the unretrieved fragment.The heavily calcified, very tough, lesion lead to the separation event.The procedure was then completed with a different device.No further patient complications were reported.The patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: returned device consisted of a coyote es balloon catheter, and the device was missing the inner shaft, part of the balloon and the tip.The remaining 8 mm of balloon was loosely folded.The balloon, port/exit notch, outer shaft and proximal weld were microscopically and tactile inspected.Inspection revealed the separated end of the balloon was jagged, and the inner shaft was separated at the distal edge of the port/exit notch.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-05327.It was reported that balloon rupture and separation occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified basilar artery (ba).The procedure was a percutaneous transluminal angioplasty for a patient with critical limb ischemia.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced with a 6f guidezilla ii pv long guide extension catheter as support for dilatation.However, upon removal, the balloon got caught in the collar of the guidezilla.The balloon ruptured and then detached inside of the guidezilla, and the detached portion was dislodged into the patient.The detached portion of the device remained in the patient.No patient symptoms occurred due to the unretrieved fragment.The heavily calcified, very tough, lesion lead to the separation event.The procedure was then completed with a different device.No further patient complications were reported.The patient's status was stable.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7601910
• MDR Text Key: 111076150
• Report Number: 2134265-2018-05328
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2021
• Device Model Number: H74939135152010
• Device Catalogue Number: 39135-15201
• Device Lot Number: 21901985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2018
• 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: GUIDE WIRE: JUPITER FC 300; INTRODUCER SHEATH: 4.5F PARENT MEDIKIT
• Patient Outcome(s): Other