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

Model Number 1867

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Event Description

It was reported that delivery shaft was fractured.The target lesion was located in the severely calcified middle left anterior descending artery.A guidezilla guide extension catheter was selected for use.During procedure, it was noted that the delivery shaft was fractured.The device was simply pulled out and there were no device fragments left inside patient's body.The procedure was completed with a different device.There were no complications reported and patient was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Analysis of the tip, distal shaft, collar, and hypotube was included microscopic and visual inspection.Inspection revealed numerous shaft kinks in the distal shaft, a partial separation at the shaft/collar area, and the collar was damaged (flattened).Inspection of the rest of the device found no other damage or defect.

Event Description

It was reported that delivery shaft was fractured.The target lesion was located in the severely calcified middle left anterior descending artery.A guidezilla guide extension catheter was selected for use.During procedure, it was noted that the delivery shaft was fractured.The device was simply pulled out and there were no device fragments left inside patient's body.The procedure was completed with a different device.There were no complications reported and patient was stable.

• Brand Name: GUIDEZILLA
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10580380
• MDR Text Key: 208340087
• Report Number: 2134265-2020-13189
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729839859
• UDI-Public: 08714729839859
• Combination Product (y/n): N
• PMA/PMN Number: K123765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2021
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0024792938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 76