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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA II CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION GUIDEZILLA II CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Difficult to Advance (2920)
Patient Problems Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)
Event Date 08/24/2021
Event Type  Injury  
Manufacturer Narrative

Initial reporter address 1: (b)(6).

 
Event Description

It was reported that the burr stuck in the lesion and a dissection occurred. The target lesion was located in the heavily calcified mid right coronary artery (rca). A 1. 25mm rotapro and a 6f guidezilla were selected for use. During the 4th or 5th run with the rotapro and a 6f guide, the burr went forward and became stuck in the rca. In attempts to dislodge the burr, a non-boston scientific workhorse wire and a 1. 1mm non-boston scientific balloon were placed proximal to the burr using a 6f buddy guide system; however, there was no success in dislodging the burr. Multiple unsuccessful attempts were made to pull on the burr using a 1. 5mm balloon inflated to 1 atm. It became easier to navigate the buddy wire and actually pass the burr but the burr was unable to be dislodged. The buddy wire and the balloon were removed. The rotapro catheter and the rotawire were cut just distal to the end of the advancer and the catheter sheath was removed. A 6f guidezilla was advanced approximately 8mm short of the burr and was unable to dislodge the burr. Another buddy catheter was used and rewired with a workhorse wire. A 2. 0mm balloon was advanced up to the burr but was unable to dislodge the burr. A 2. 5 x 6mm nc balloon was inflated to 20atm but was unable to remove the burr. The balloon and buddy wire were removed. A new guidezilla was advanced over the rotapro shaft and rotawire up to the burr. Glyceryl trinitrate (gtn) was added and was able to remove the burr. The posterolateral artery (pla) was lost and the patient's blood pressure dropped. A dissection was noted in the rca. A 2. 5 x 20mm synergy was used to post dilate the lesion up to 3. 5mm and cover the dissection. A small balloon was send back down the pla to re-establish some flow. The patient was admitted to the intensive care unit for the night to monitor pressures. The patient's status was stable.

 
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Brand NameGUIDEZILLA II
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12387888
MDR Text Key268812329
Report Number2134265-2021-10942
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAS
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 08/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received08/24/2021
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/30/2021 Patient Sequence Number: 1
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