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

Model Number	83779
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coil fracture occurred.The target lesion was located in the celiac trunk aneurysm.A 14mm x 30cm 2d interlock coil was selected for treatment.During the procedure, an obvious resistance was felt when advancing the coil.Upon withdrawal, there was also resistance, and the body of coil was found fractured inside the catheter.The procedure was completed with another of the same device.No complications were reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection confirmed that only the introducer sheath was returned.No damaged were observed in the section returned.Functional inspection could not be performed due only the introducer sheath was returned.Based on the evidence, the reported allegation of main coil difficulty advancing and withdrawal from the catheter was confirmed, since there were no damages found during product inspection could have contributed to the reported issue.
Event or Problem Description
It was reported that coil fracture occurred.The target lesion was located in the celiac trunk aneurysm.A 14mm x 30cm 2d interlock coil was selected for treatment.During the procedure, an obvious resistance was felt when advancing the coil.Upon withdrawal, there was also resistance, and the body of coil was found fractured inside the catheter.The procedure was completed with another of the same device.No complications were reported, and the patient was in good condition after the procedure.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19949934
• Report Number: 2124215-2024-48426
• Device Sequence Number: 8810781
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 08/15/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0032435562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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 Age: 70 YR
• Patient Sex: Male