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

Model Number	82885
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection performed.The main coil returned outside the coil introducer.The plunger and retaining clip were not returned.The coil introducer was inspected and no anomalies were noted.The coil was inspected and was found stretched.Microscopic inspection performed on main coil.The zap tip has a smooth surface.The main coil was kinked.Dimensional inspection on main coil was performed.The main coil failed specification for the number of fiber bundles.The remainder measurements that were inspected were within specification.
Event or Problem Description
Reportable based on device analysis completed on 07feb2020.It was reported that coil the was stuck.The target lesion was located in a blood vessel.A 4mm x 30mm 2d helical-35 was selected for an emergency hemorrhage embolization procedure.During the procedure, an angiography catheter was used to advanced the coil.Subsequently, the device could not be pushed and the got coil stuck in the connection part of the tip of the angiocatheter.The device was removed with the catheter from the patent's body without any intervention.The procedure was completed with another of same device.No patient complications were reported and the patient was stable.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: 9694285
• Report Number: 2134265-2020-01261
• Device Sequence Number: 2825207
• Product Code: KRD
• UDI-Device Identifier: 08714729237228
• UDI-Public: 08714729237228
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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: 09/11/2021
• Device Model Number: 82885
• Device Catalogue Number: 82885
• Device Lot Number: 0022640851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 70