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

Model Number	1867
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the collar was fractured.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified right coronary artery.A guidezilla guide extension catheter was selected for use.During procedure, it was noted that the collar was fractured.The device was simply pulled out completely from the patient's body.The procedure was completed with another of the same device.No complications reported and patient was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Analysis of the tip, distal shaft, collar and hypotube included microscopic and visual inspection.Inspection revealed a partial separation at the shaft/collar area, and the collar was damaged (edge lifted away from collar).Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that the collar was fractured.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified right coronary artery.A guidezilla guide extension catheter was selected for use.During procedure, it was noted that the collar was fractured.The device was simply pulled out completely from the patient's body.The procedure was completed with another of the same device.No complications reported and patient was stable.

• Brand Name: GUIDEZILLA
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11223268
• Report Number: 2134265-2021-00636
• Device Sequence Number: 14387654
• 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,Followup
• Report Date (Section B): 03/17/2021

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: 0025758717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 62