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

Model Number	82865
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: unit returned in a generic plastic bag.The unit returned with the catheter broken, as part of overall visual revision.The returned device matches with upn provided by the customer.Only a main coil and microcatheter were returned for this complaint.The microcatheter was received cut.The coil was inside the micro catheter.No other damages were found.The coil was removed from the microcatheter without problems, no resistance was felt.After the removal of the coil was noted kinked and stretched.The apex and base zap tip were inspected and no damages were found.Dimensinal inspection of the apex zap tip, base zap tip, and primary coil od were within the specifications.There were fiber bundles missing.
Event or Problem Description
Reportable based on device analysis completed on 20jul2020.It was reported that the coil was stuck in the microcatheter.The target lesion area was located at the liver.A 4 mm/ 4 mm vortx - 18 was selected for an arteriovenous fistula embolization.During the procedure, the coil got stuck at the hub part of the micro catheter and it could not be pushed.The coil was removed together with the microcatheter.The procedure was completed with another of the same device.No complications reported and the patient was stable post procedure.However, device analysis revealed missing fiber bundles.

• Brand Name: VORTX - 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: 10355941
• Report Number: 2134265-2020-10327
• Device Sequence Number: 16949514
• Product Code: KRD
• UDI-Device Identifier: 08714729158882
• UDI-Public: 08714729158882
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 08/03/2020

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: 08/20/2021
• Device Model Number: 82865
• Device Catalogue Number: 82865
• Device Lot Number: 0022680888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 71