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

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.

• Brand Name: GUIDEZILLA II
• Type of Device: CATHETER, 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 Key: 12387888
• MDR Text Key: 268812329
• Report Number: 2134265-2021-10942
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 08/30/2021
• 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
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention