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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II PV LONG GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II PV LONG GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number H74939395003506L0
Device Problem Device Damaged by Another Device (2915)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/23/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Same case as mdr id: 2134265-2018-05328. 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 unreprieved 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 NameGUIDEZILLA¿ II PV LONG GUIDE EXTENSION CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
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 Key7601915
MDR Text Key111100471
Report Number2134265-2018-05327
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberSIMILAR
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 HEALTH PROFESSIONAL
Device EXPIRATION Date08/06/2019
Device MODEL NumberH74939395003506L0
Device LOT Number21100104
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 Received06/15/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/08/2017
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
GUIDEWIRE: JUPITER FC 300; INTRODUCER SHEATH: 4.5F PARENT MEDIKIT
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