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

Model Number	83775
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a snare was used to recover the coil and the procedure was cancelled.The 9.8mmx2mm target lesion was located in the mildly tortuous anterior superior pancreaticoduodenal artery.A 3mmx10cm idc was selected for use.During the procedure, it was noted that the tip of the coil was caught in the coil that was embolized earlier and early detached in the distal part of the catheter when it was forcibly pulled back.A snare was used for removal and device was recovered.The procedure was not completed.No patient complications were reported.
Additional Manufacturer Narrative
F10.Impact codes corrected.
Event or Problem Description
It was reported a snare was used to recover the coil and the procedure was cancelled.The target lesion was located in the mildly tortuous and non calcified anterior superior pancreaticoduodenal artery.A 3mmx10cm idc was selected for use.During the procedure, it was noted that the tip of the coil was caught in the coil that was embolized earlier and it was noted that the coil got early detached in the distal part of the catheter when it was forcibly pulled back.A snare was used and recovered.The procedure was not completed.No patient complications were reported it was further reported that the procedure was sufficient and no additional procedure is planned.

• 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: 15188317
• Report Number: 2124215-2022-29116
• Device Sequence Number: 5808832
• Product Code: KRD
• UDI-Device Identifier: 08714729158721
• UDI-Public: 08714729158721
• 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,Followup
• Report Date (Section B): 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2024
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0028676942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown