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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: visual inspection observed that the main coil, coil introducer, and coil plunger were returned for this complaint.The main coil was stuck within the coil introducer and was kinked and stretched.The coil was advanced through the introducer coil and resistance was noticed.The microscopic inspection observed there were no anomalies noticed on the apex zap tip.The base zap tip was found twisted.Dimensional inspection of the main coil observed the outer diameter of the primary coil, apex, and base zap tip were within specification.However, fiber bundles were missing due to the coil being stretched.
Event or Problem Description
Reportable based on device investigation completed on (b)(6) 2021.It was reported that the spring coil was stuck in the catheter.The target lesion was located in the upper gastrointestinal tract.A 6mm/6.7 mm vortx diamond - 18 was selected for use.During the procedure, it was noted that the spring coil got stuck in the hub of the catheter during delivery.The device was simply pulled out and the procedure was completed with another of the same device.There were no complications reported and the patient is stable.However, device analysis revealed that there were fiber bundles missing.

• 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: 12409826
• Report Number: 2134265-2021-11015
• Device Sequence Number: 14500891
• Product Code: KRD
• UDI-Device Identifier: 08714729201205
• UDI-Public: 08714729201205
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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: 09/10/2021
• Device Model Number: 82875
• Device Catalogue Number: 82875
• Device Lot Number: 0022780714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 72