MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83775
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual inspection was performed and it was observed that the main coil, the introducer sheath and the pusher wire were returned.The main coil and the pusher wire were not interlocked.The main coil was observed stretched, kinked and it was observed detached in the coil arm section.The original box was returned, and it was observed that the pouch box information matches with the complaint information.The pusher wire was kinked in the distal section.No more damages were observed.Microscope inspection was performed and under the microscope was observed that the main coil was detached in the coil arm section.Functional inspection was performed and the functional test could not be performed due the main coil and the delivery wire were not interlocked.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023: it was reported that the device was unable to advance.The target lesion was located in moderately tortuous vessel.A 4mm x 12cm idc 18 coil was selected for use.During the procedure, the coil got stuck within the microcatheter and the device was unravel.The coil was removed together with the microcatheter.The procedure was completed with another of the dame device.No complications were reported.However, returned device analysis revealed that the main coil was detached in the coil arm section.

• Brand Name: IDC
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16747339
• Report Number: 2124215-2023-16807
• Device Sequence Number: 14309981
• Product Code: KRD
• UDI-Device Identifier: 08714729158752
• UDI-Public: 08714729158752
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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: 04/09/2025
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0029368694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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