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

Model Number	82875
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn provided by the customer.Visual inspection was performed.The retaining clip, the coil introducer and the plunger were returned for this compliant, the main coil was not returned.The plunger was returned inside the coil introducer.No damages were found in the device.
Event or Problem Description
Reportable based on device analysis completed on 30apr2020.It was reported that the coil failed to separate.The target lesion area was located in the fundus of the stomach.A 3mm/3.3mm vortx-18 diamond embolic was selected for use.During the procedure, coil deployment failed.The device was removed all together with the catheter.The procedure was completed with another of the same device.No complications reported.However, device analysis revealed that the main coil was not returned.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2020.It was reported that the coil failed to separate.The target lesion area was located in the fundus of the stomach.A 3mm/3.3mm vortx-18 diamond embolic was selected for use.During the procedure, coil deployment failed.The device was removed all together with the catheter.The procedure was completed with another of the same device.No complications reported.However, device analysis revealed that the main coil was not returned.It was further reported that the coil was scrapped by the physician after it was completely removed from the patient.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn provided by the customer.Visual inspection was performed.The retaining clip, the coil introducer and the plunger were returned for this compliant, the main coil was not returned.The plunger was returned inside the coil introducer.No damages were found in the device.

• 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: 10026037
• Report Number: 2134265-2020-06034
• Device Sequence Number: 2937903
• Product Code: KRD
• UDI-Device Identifier: 08714729324874
• UDI-Public: 08714729324874
• 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,Followup
• Report Date (Section B): 05/11/2020

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: 12/03/2021
• Device Model Number: 82875
• Device Catalogue Number: 82875
• Device Lot Number: 0023132354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 68