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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 Problems Device Damaged by Another Device (2915); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

Same case as mdr id# 2134265-2017-13166. It was reported that the guide extension catheter damaged another device. The 90% strenosed target lesion was located in the severely tortuous and moderately calcified obtuse marginal branch. A 3. 00 x 20mm synergy¿ stent delivery system (sds) was advanced and failed to cross the lesion. A guidezilla ii guide extension catheter was then used on the second attempt to advance the synergy sds but it still failed to cross the lesion. When the physician tried to remove the synergy¿ sds, the proximal end of the stent met with the distal end of the guidezilla ii and the synergy stent became flared. Upon further removal, the stent dislodged from the delivery system. The physician tried to remove the dislodged stent using two parallel guide wires with the delivery catheter. However, strong resistance was felt and the synergy sds separated at its exit port. Only the proximal portion of the sds could be removed. Subsequently, the guidezilla and the guide catheter were removed. A new 8f sheath was then inserted and a snare catheter was advanced and retrieved the dislodged stent. At unknown timing, the distal portion of the delivery catheter was removed and nothing has been left behind the patient's body. No patient injuries were reported.

 
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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 Key7208731
MDR Text Key98049937
Report Number2134265-2018-00717
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK163314
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 12/23/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK963
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 01/20/2018 Patient Sequence Number: 1
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