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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
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.
 
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Brand NameCOYOTE¿ ES
Type of DeviceCATHETER, 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 Key7601910
MDR Text Key111076150
Report Number2134265-2018-05328
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K080982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
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 Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/22/2021
Device Model NumberH74939135152010
Device Catalogue Number39135-15201
Device Lot Number21901985
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/14/2018 Patient Sequence Number: 1
Treatment
GUIDE WIRE: JUPITER FC 300; INTRODUCER SHEATH: 4.5F PARENT MEDIKIT
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