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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 H7493933515060
Device Problems Difficult to Remove (1528); Device Damaged by Another Device (2915); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: the guidezilla device was returned bloody. The hypotube, collar, distal shaft and tip were microscopically and tactile inspected. Inspection revealed numerus kinks in the distal shaft, a kink in the hypotube located 2 mm from the collar, tip damage (misshapen/inverted/abrasions), and shaft damage (braid broken/outer shaft material separated) located 6. 5 cm from the collar. The shaft damage appears to have been caught on something and then torn, leaving the ptfe liner intact. 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

Reportable based on device analysis completed on (b)(6) 2018. It was reported that there was difficulty removing the stent through the catheter and the tip became damaged. A 6f guidezilla¿ ii guide extension catheter was selected for a percutaneous coronary intervention, in the severely tortuous, moderately calcified, and 90% stenosed right coronary artery (rca) , for a patient with a leiomyoma. An attempt was made to stent with an non-bsc stent, but it failed to cross the rca. When attempting to remove the stent, the stent's strut became deformed and the tip was damaged when it was tugged at the guidezilla tip. The guidezilla tip was also deformed. No additional interventions were performed. The procedure completed with a new guidezilla ii device and the synergy stent successfully. No patient complications were reported. The patients condition after the procedure was good. However, device analysis revealed material separation at the shaft.

 
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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 Key7362841
MDR Text Key103413151
Report Number2134265-2018-01978
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeKR
PMA/PMN NumberK163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/22/2019
Device MODEL NumberH7493933515060
Device LOT Number20802030
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/23/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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