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

Model Number	82875
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 05-oct-2018.It was reported that the coil was stuck in the catheter.A 4mm/3.7 mm vortx diamond - 18 was selected for use.During the procedure, it was noted that the coil could not be pushed out and it was stuck.Furthermore, after withdrawing the catheter and coil outside the patient, the physician pushed it out with high persistence.The procedure was completed with another of the same device.No patient complications were reported and the patient's status post-procedure was stable.However, device analysis revealed that the main coil zap tip was detached and not returned.Device evaluated by mfr: the device was returned for analysis.The coil, the coil plunger and the coil introducer were returned for this complaint; the retaining clip was not returned.The coil returned inside the coil introducer.The coil was deployed and some resistance was felt during the procedure.Microscopic inspection of the main coil revealed that the main coil showed some damages indicating it was highly manipulated.The main coil had a detached zap tip and it was not returned; the other zap tip has a smooth surface.Besides, the main coil was stretched in one of it ends and it was kinked.Dimensional inspection of the main coil revealed that the other zap tip, the primary coil outer diameter and fiber bundles were within specification.

• 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: 8002248
• Report Number: 2134265-2018-62277
• Device Sequence Number: 1190149
• Product Code: KRD
• UDI-Device Identifier: 08714729324881
• UDI-Public: 08714729324881
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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: 12/23/2020
• Device Model Number: 82875
• Device Catalogue Number: 82875
• Device Lot Number: 0021645734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1