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

Model Number	83775
Medical Device Problem Codes	Contamination (1120); Material Integrity Problem (2978); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterility of the device was compromised.A 2mmx2cm idc-18 soft coil was selected for use.When the device was received in the health care facility from shipping, it was observed that the package was smashed in the center of the hoop.It was noted that the sterility of the device was compromised.The outer package was not damaged.There was no patient involvement.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was not received for product analysis.The box and the device were not returned, nevertheless the costumer attached a picture of the box, and it was observed kinked at several parts.The device was not observed at the pictures provided.No other issues were identified during media analysis.H3 other text : media.
Event or Problem Description
It was reported that the sterility of the device was compromised.A 2mmx2cm idc-18 soft coil was selected for use.When the device was received in the health care facility from shipping, it was observed that the package was smashed in the center of the hoop.It was noted that the sterility of the device was compromised.The outer package was not damaged.There was no patient involvement.

• 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: 15847057
• Report Number: 2124215-2022-45182
• Device Sequence Number: 5076718
• Product Code: KRD
• UDI-Device Identifier: 08714729158684
• UDI-Public: 08714729158684
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 06/12/2025
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0029753621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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