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

Model Number	1867
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Analysis of the tip, distal shaft, collar and hypotube included microscopic and visual inspection.Inspection revealed a complete separation at the collar/shaft area with the ptfe pulled out of the collar, tip damage (flattened), the shaft was damaged (flattened) for a length of 15.8cm, and numerous kinks in the hypotube.Inspection found no other damage or defect with the device.The guide catheter used with the guidezilla was not returned for analysis.A test guide was used to conduct device testing.The tip of the guidezilla was inserted into the hub of the test guide, but it could only be advanced for approximately 1.6cm and then stopped.The shaft could not be advanced past the beginning of the shaft damage.
Event or Problem Description
Reportable based on device analysis completed on 18feb2021.It was reported that the guidezilla could not enter the guide catheter.The target lesion was located in the coronary artery.A 5-in-6 guidezilla catheter guide extension was selected for use.During procedure, it was noted that the guidezilla could not enter the guide catheter.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that a complete separation at the collar/shaft area occurred with the ptfe pulled out of the 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: 11393513
• Report Number: 2134265-2021-02597
• Device Sequence Number: 1220191
• 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): 03/01/2021

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: 06/30/2022
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0025656580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 61