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

Model Number	1867
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The hypotube, collar, distal shaft and tip was microscopically and visually inspected.Visual inspection revealed that the collar is separated and the ptfe is still holding the two ends together.There are multiple kinks along the hypotube.There is a flat spot 7mm from the tip.Microscopic inspection revealed no additional damages.There is blood present inside the device.
Event or Problem Description
Reportable based on device analysis completed on 10mar2021.It was reported that the tip was kinked.The 85% stenosed target lesion area was located in a severely tortuous and severely calcified left anterior descending artery.A 145, 5-in-6 guidezilla catheter guide extension was selected for use in a percutaneous coronary intervention.During the procedure, the guidecatheter tip was damaged and kinked throughout use.The procedure was completed with another of the same device.No complications reported, and the patient was stable.However, device analysis revealed a separated collar.

• Brand Name: GUIDEZILLA
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11570846
• Report Number: 2134265-2021-03614
• Device Sequence Number: 11662404
• Product Code: DQY
• UDI-Device Identifier: 08714729839859
• UDI-Public: 08714729839859
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2021
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0024403999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 70