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

Model Number	83779
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: event date not provided and estimated based on initial aware date.Device evaluated by mfr.: the device was returned for analysis.The visual inspection revealed that the main coil was returned stuck inside a non-boston scientific catheter.After remove the main coil from the non-boston scientific catheter it was observed that it was stretched and detached/separated from the interlocking arm section.The microscope inspection shows the main coil was detached/separated at interlocking arm section.The functional inspection or test could not be performed due only the main coil was returned.The dimensional inspection of the main coil passed the test except for the coil arm outer diameter.
Event or Problem Description
Reportable based on device analysis completed on 02dec2022.It was reported that advancing difficulties were encountered.The target lesion was located in the pulmonary artery.A 2mm x 6cm and 3mm x 6cm pe f-idc coil were selected for use.However, both device could not be delivered or withdrawn outside the catheter.The procedure was completed with another of the same device.No complications were reported and the patient's status was stable.However, returned device analysis revealed that the 2mm x 6cm coil was detached/separated at the interlocking arm section.

• Brand Name: INTERLOCK
• 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: 16016540
• Report Number: 2124215-2022-53791
• Device Sequence Number: 14901346
• Product Code: KRD
• UDI-Device Identifier: 08714729845270
• UDI-Public: 08714729845270
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2022

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: 05/31/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027594944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: CORDIS C2
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 65 KG