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

Model Number	1867
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2020
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 multiple flat spots along the distal shaft.The collar is separated, and the polytetrafluoroethylene (ptfe) is still holding the two ends together.Microscopic inspection revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the collar is separated and appears to have been kinked prior to separating.
Event or Problem Description
Reportable based on device analysis completed on 13jan2021.It was reported that device was kinked.The severely stenosed target lesion was located in the distal right coronary artery.A guidezilla guide extension catheter was selected for use.During procedure, it was noted that the connection section of the device was kinked and was then withdrawn immediately.The procedure was completed with another of the same device.No complications reported and patient was stable.However, device analysis revealed collar separation.

• Brand Name: GUIDEZILLA
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11223423
• Report Number: 2134265-2021-00645
• Device Sequence Number: 3740030
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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: 07/23/2022
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0025758708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 87