MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2D HELICAL - 35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	82885
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and functional inspection revealed that a catheter and coil were returned for this complaint.The coil was stuck inside the catheter.It was necessary to cut the catheter in order to release the coil.The main coil was found stretched and kinked.No more damages were found in the device.During the product analysis the investigator was unable to remove the coil from the catheter due to the stretched and kinked.The investigator cut off the catheter and successfully removed the coil.A microscopic and dimensional inspection revealed that the proximal zap tip and distal tip of the main coil was within its specification aside from the fiber bundles which was missing due to the coil stretching.
Event or Problem Description
Reportable based on device analysis completed on 26mar2020.It was reported that the coil got stuck in the catheter.The target lesion was located in the portal vein.A 7mmx40mm 2d helical - 35 embolic coil was selected for use.During procedure, it was noted that the coil got stuck inside the delivery catheter.The device was removed as a unit and another of the same device was used to complete the procedure.No patient complications were reported and patient status was good.However, device analysis revealed missing fiber bundles.

• Brand Name: 2D HELICAL - 35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9913755
• Report Number: 2134265-2020-04202
• Device Sequence Number: 14311619
• Product Code: KRD
• UDI-Device Identifier: 08714729158851
• UDI-Public: 08714729158851
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/01/2020

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: 05/14/2021
• Device Model Number: 82885
• Device Catalogue Number: 82885
• Device Lot Number: 0022119321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1