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

Model Number 1867

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the tip of the device was fractured.A 145, 5-in-6 guidezilla catheter guide extension was selected for use in a percutaneous coronary intervention.During the procedure, it was noted that the tip of the device was fractured in the guiding catheter.The device was removed with the catheter.The procedure was completed with another of the same device.No complications reported and the patient is stable.

Manufacturer Narrative

D4.Device batch/lot# updated from 0024521487 to 0023623529, based on device return.E1.Initial reporter facility name: (b)(6) medicine.Device evaluated by manufacturer: the device was returned for analysis.Returned device consisted of a guidezilla guide extension catheter.The device was bloody.Analysis of the tip, distal shaft, hypotube and hub/strain relief included microscopic and visual inspection.Inspection revealed a complete separation of the distal shaft from the collar, and the collar was damaged.Inspection of the rest of the device found no other damage or defect.

Event Description

It was reported that the tip of the device was fractured.A 145, 5-in-6 guidezilla catheter guide extension was selected for use in a percutaneous coronary intervention.During the procedure, it was noted that the tip of the device was fractured in the guiding catheter.The device was removed with the catheter.The procedure was completed with another of the same device.No complications reported and the patient is 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: 10425519
• MDR Text Key: 203503917
• Report Number: 2134265-2020-11269
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2021
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0023623529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 75