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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ CATHETER, PERCUTANEOUS Back to Search Results
Model Number H7493924215050
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2018
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis. The returned product consisted of a guidezilla guide extension catheter in two pieces. The device was bloody. The hypotube, collar, distal shaft and tip were microscopically and tactile inspected. Inspection revealed a complete separation at the collar. There were numerous kinks throughout the device. 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 2134265-2018-05372 and mdr id 2134265-2018-06531. Reportable based on device analysis completed on 28-jun-2018. It was reported that guidezilla damaged another device. The 38mm in length and 3mm in diameter, 98% stenosed target lesion was located in the severely tortuous and severely calcified distal mid right coronary artery (rca). During a percutaneous coronary intervention, the physician attempted to inflate a 2. 50mm/10mm flextome¿ cutting balloon¿; however, the device could not cross the lesion and the proximal end of the balloon burst under 7atm. The device was not fractured and was completely removed from the patient's body. Subsequently, a 1. 50mm x 12mm and two 2. 50mm x 15mm emerge¿ balloon catheters were used to dilate the lesion; however, all three delivery shafts of the balloon were kinked and the tips were damaged. The physician then used a non bsc balloon and successfully inflated the lesion. A guidezilla guide extension catheter was then used to facilitate implant of a non bsc stent. However, the guidezilla scratched the stent and caused the stent to lift up. The stent was replaced with another non bsc stent which was deployed successfully. A 2. 5mm/12mm quantum¿ maverick¿ was then used for post dilation; however, the tip of the balloon was damaged and deformed causing the stent to migrate. The patient was sent for surgery for thoracotomy of the coronary artery bypass graft. There were no further patient complications reported. However, device analysis revealed a complete separation at the collar of the guidezilla.

 
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Brand NameGUIDEZILLA¿
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 Key7699111
MDR Text Key114419609
Report Number2134265-2018-06441
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCN
PMA/PMN NumberK123765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 06/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/13/2019
Device MODEL NumberH7493924215050
Device Catalogue Number39242-1505
Device LOT Number0021127905
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/08/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/13/2017
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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