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

Model Number	1867
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterility of the device was compromised.The target lesion was located in the left coronary artery.A guidezilla guide extension catheter was selected for use.Upon opening the outer device package, it was found that the inner package was not sealed.The possibility of bacterial contamination was considered, thus the physician changed to another of the same device to complete the procedure.No patient complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that the sterility of the device has been compromised.The target lesion was located in the left coronary artery.A guidezilla catheter-guide extension was selected for use.During unpacking, it was noted that the inner package was not sealed.The possibility of bacterial contamination was considered, thus the physician changed another same device to complete the procedure.No patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the guidezilla guide extension catheter inside of the hoop and product pouch.The shelf box was not returned for analysis.The product pouch and tyvek seal were visually examined.Inspection of the device revealed that the product pouch was received opened.The top right-hand corner, along the top, and the top half of the right side was peeled back/opened.There was no other irregularities or damage to the packaging.The product pouch and tyvek seal were inspected further, and it was found that there was evidence of the tyvek seal on the product pouch.This indicates that when the device was shipped out the product pouch was sealed, and the seal was complete.For the seal to have been pulled back, it had to have been after the device was taken out of the shelf box/packaging at the facility.The product pouch was opened.However, the seal shows evidence of tyvek on the seal, indicating the product pouch was sealed when manufactured.

• Brand Name: GUIDEZILLA
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11969592
• Report Number: 2134265-2021-06937
• Device Sequence Number: 16937188
• 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): 07/30/2021

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: 09/23/2022
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0026064699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 70