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

Model Number 1873

Device Problems Failure to Advance (2524); Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that stent became damaged inside the guidezilla ii.The 95% stenosed target lesion was located in the severely tortuous and mildly calcified right posterior descending artery.Due to difficulty in crossing the posterior descending artery a guidezilla ii was selected to aid in delivering a 2.25 x 38mm synergy xd stent.The synergy xd stent could not cross the lesion.The synergy xd stent was forcibly withdrawn and became damaged within the guidezilla ii guide extension catheter.Both devices were removed together.The procedure was completed with a different device.No patient complications were reported.

• 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: 11891378
• MDR Text Key: 252933050
• Report Number: 2134265-2021-06892
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: 08714729939474
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2021
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0024882315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1