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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number UNK963
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2018
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the 7f guidezilla ii guide extension catheter. The device was bloody. The hypotube, collar, distal shaft and tip was microscopically and tactile inspected. Inspection revealed tip damage (misshapen) and kinks in the distal shaft located 6 cm and 17. 5 cm from the tip. The inner diameter of the tip was measured/pinned and meeting specification. The interventional device used in the procedure was not returned for analysis, so a test device was used to functionally test the guidezilla. Functional testing consisted of loading a 4. 0 stented balloon catheter into the collar of the guidezilla, and advancing out through the tip of the guidezilla. The interventional device advanced smoothly and without issue. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event. (b)(4).

 
Event Description

Same case as mdr id: 2134265-2018-05362. It was reported that device interaction occurred. The chronic totally occluded target lesion was located in the right coronary artery. A 3. 50mm x 8mm nc emerge® balloon catheter was advanced for dilation. However, during the procedure the balloon ruptured in the artery. Upon removal of the device, it was believed that the balloon snagged on the 7f guidezilla¿ ii guide extension catheter. The balloon then detached from the shaft of the balloon. The balloon was completely removed by pulling the guide wire and guidezilla. Then aspiration was performed to remove the balloon fragments. No damage was noted on the guidezilla. The procedure was then completed with new emerge balloons and synergy stents. No further patient complications were reported and the patient's status was good.

 
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Brand NameGUIDEZILLA¿ II 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 Key7602168
MDR Text Key111108782
Report Number2134265-2018-05363
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
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 Date09/25/2019
Device MODEL NumberUNK963
Device LOT Number21305995
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/31/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/26/2017
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
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