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

Model Number	83775
Medical Device Problem Codes	Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual inspection shows, only the main coil was returned, and it was observed that it was stretched and the interlocking arm was detached.Microscope inspection was performed and under microscope it was observed that the interlocking arm of the main coil was detached.
Event or Problem Description
Reportable based on device analysis completed on 26 jan 2023.It was reported that the coil was damaged.The target lesion was located in the moderately tortuous and non-calcified internal iliac artery.A 4mm x 12cm idc coil was selected for use.During unpacking, it was noted that the distal port of the device was stretched.The device was not placed inside the body and the procedure was completed with another of the same device.No complications were reported.However, returned device analysis revealed the interlocking arm was found detached.

• 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16424352
• Report Number: 2124215-2023-06099
• Device Sequence Number: 20255304
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

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: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/22/2023
• 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