MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VORTX DIAMOND - 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	82875
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sterility was compromised.A vortx diamond-18 device was selected for an embolization procedure.As the device was being removed from the inner packaging, the pusher jumped out of the packaging.The sterility was compromised.Another of the same device was used to complete the procedure.No adverse effects to the patient were reported and the patient was stable post procedure.
Event or Problem Description
It was reported that sterility was compromised.A vortx diamond-18 device was selected for an embolization procedure.As the device was being removed from the inner packaging, the pusher jumped out of the packaging.The sterility was compromised.Another of the same device was used to complete the procedure.No adverse effects to the patient were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device analysis by mfr: visual inspection of the returned device showed that the main coil was returned inside the coil introducer.The plunger and retaining clip were also returned.The coil introducer was inspected and no anomalies were noted.The coil was inspected and not abnormalities were found.No damages were found in the device.Functional inspection showed that the coil was able to be advanced through the coil introducer without problem.No resistance was felt.

• Brand Name: VORTX DIAMOND - 18
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9416790
• Report Number: 2134265-2019-14960
• Device Sequence Number: 1725178
• Product Code: KRD
• UDI-Device Identifier: 08714729324898
• UDI-Public: 08714729324898
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 09/17/2021
• Device Model Number: 82875
• Device Catalogue Number: 82875
• Device Lot Number: 0022811033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1