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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 Problems Partial Blockage (1065); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2014
Event Type  malfunction  
Event Description
It was reported that the catheter extension was blocked and shaft fracture occurred.The target lesion was located in the right coronary artery (rca).The doctor gained access to the intended location with the use of a 6f runway wrp sh guide catheter and a guidezilla 145, 5-in-6 extension guide catheter.Balloon angioplasty was then performed with a 2.5x20mm emerge balloon catheter then a 3.0x15mm non bsc balloon catheter.During removal of the 3.0x15mm non bsc balloon catheter from the lesion, through the guidezilla extension catheter, resistance was felt (physician stated it felt like a bump).The physician tried to inject contrast and said there was no contrast injected through.The balloon was removed from the guide and the guidezilla, and tried to shoot contrast again, and no contrast came out.The physician went to remove the guidezilla out of the guide, and the catheter separated.The physician was able to withdraw everything from the patient.The procedure was completed with the placement of a 3.5x26mm non bsc stent.No patient complications were reported and the patient status is fine.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by manufacturer: a visual examination identified the guidezilla guide extension catheter was received in two (2) pieces.There was blood inside and outside of the shaft.Microscopic examination of the distal shaft presented no damage or irregularities.A complete separation at the collar/proximal shaft bond.The ptfe was pulled out of the collar and was attached to the distal shaft.Examination of the collar presented no damage or irregularities.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues or damage were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that the catheter extension was blocked and shaft fracture occurred.The target lesion was located in the right coronary artery (rca).The doctor gained access to the intended location with the use of a 6f runway wrp sh guide catheter and a guidezilla 145, 5-in-6 extension guide catheter.Balloon angioplasty was then performed with a 2.5x20mm emerge balloon catheter then a 3.0x15mm non bsc balloon catheter.During removal of the 3.0x15mm non bsc balloon catheter from the lesion, through the guidezilla extension catheter, resistance was felt (physician stated it felt like a bump).The physician tried to inject contrast and said there was no contrast injected through.The balloon was removed from the guide and the guidezilla, and tried to shoot contrast again, and no contrast came out.The physician went to remove the guidezilla out of the guide, and the catheter separated.The physician was able to withdraw everything from the patient.The procedure was completed with the placement of a 3.5x26mm non bsc stent.No patient complications were reported and the patient status is fine.
 
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Brand Name
GUIDEZILLA?
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4290015
MDR Text Key19088987
Report Number2134265-2014-07308
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/11/2016
Device Model NumberH7493924215050
Device Catalogue Number39242-1505
Device Lot Number17277020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age79 YR
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