MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMPLEX HELICAL - 18; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	82735
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil, the coil plunger and main coil introducer were returned for this complaint.The retaining clip was not returned.The coil plunger was inspected, and no damages were noticed.The coil introducer was inspected, and no damages were noticed.The main coil was stretched and kinked.The zap tip has a smooth surface.The dimensional inspection revealed that the outer diameter (od) at the zap tip and primary coil were found to be within specification.However, there were missing fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 02mar2022.It was reported that the coil got stuck.A 8mmx12mm complex helical was selected for use.During the procedure, while pushing the 8mmx12mm complex helical with wire, it was noted that the coil got stuck within the microcatheter.The procedure was completed with a different device.There were no patient complications reported.However, device analysis revealed that there were missing fiber bundles.

• Brand Name: COMPLEX HELICAL - 18
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13897204
• Report Number: 2134265-2022-03248
• Device Sequence Number: 4065105
• Product Code: KRD
• UDI-Device Identifier: 08714729324072
• UDI-Public: 08714729324072
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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: 04/20/2024
• Device Model Number: 82735
• Device Catalogue Number: 82735
• Device Lot Number: 0027358364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown