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

Model Number	82875
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was protruding from the microcatheter's tip during removal.The target lesion was located in the moderately tortuous vein.A 3mm/3.3 mm vortx diamond 18 was selected for use.During the procedure, it was noted that the coil was stuck inside the microcatheter.The coil was removed together with the micro catheter; however, it was further noted that the coil protruded from the microcatheter's tip during removal and was found bent.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the coil was protruding from the microcatheter's tip during removal.The target lesion was located in the moderately tortuous vein.A 3mm/3.3 mm vortx diamond 18 was selected for use.During the procedure, it was noted that the coil was stuck inside the microcatheter.The coil was removed together with the micro catheter; however, it was further noted that the coil protruded from the microcatheter's tip during removal and was found bent.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil returned inside the coil introducer, besides the plunger was returned.The coil introducer was inspected and the tip was found kinked.The coil was inspected and was found kinked.The retaining clip was removed, the plunger was introduced and the coil was advanced through the coil introducer; however the main coil was removed with some resistance.The zap tip has a smooth surface.One of the zap tip was found damage.Dimensional inspection of the main coil components have met and passed the specifications.

• 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: 9279465
• Report Number: 2134265-2019-13368
• Device Sequence Number: 2388863
• Product Code: KRD
• UDI-Device Identifier: 08714729324874
• UDI-Public: 08714729324874
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/17/2019

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: 01/26/2021
• Device Model Number: 82875
• Device Catalogue Number: 82875
• Device Lot Number: 0021788832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROGREAT19 - MICRO CATHETER; PROGREAT19 - MICRO CATHETER