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

Model Number	83779
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that a foreign metal was detached from the protective sheath.A 3mmx6cm interlock coil was selected for use.During the procedure, embolization was performed with a total of three free coils and one controllable coil were used.Consequently, after opening the package of the 3mmx6cm coil, it was found that a foreign metal detached from the protective sheath.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6) college.Device evaluated by manufacturer: the device was returned for analysis.A pusher wire and introducer sheath were returned for this complaint.The twist lock of the introducer sheath had been opened.The introducer sheath was inspected, and no anomalies were noted.The pusher wire was inspected, and no damages was found.The proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies were noticed.
Event or Problem Description
It was reported that a foreign metal was detached from the protective sheath.A 3mmx6cm interlock coil was selected for use.During the procedure, embolization was performed with a total of three free coils and one controllable coil were used.Consequently, after opening the package of the 3mmx6cm coil, it was found that a foreign metal detached from the protective sheath.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12247569
• Report Number: 2134265-2021-09753
• Device Sequence Number: 2796132
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 11/01/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026442887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR