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

Model Number	83779
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 13nov2023.It was reported that there was obvious resistance, and the coil could no longer be pushed after about half of its release.The target lesion was located in the splenic artery.An 8mm x 20cm interlock was selected for use.During the procedure, it was noted that there was obvious resistance, and the coil could no longer be pushed after about 1/2 of its release.The coil was withdrawn, and it was noted that the coil was stretched.The procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the main coil was detached.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter address 2: (b)(6).Device evaluated by mfr: only the main coil was returned for the analysis, and it was observed that the main coil was stretched, bent and detached at the middle section.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.The functional could not be performed due only the main coil was returned for the analysis.Dimensional inspection of the main coil revealed the components were within specification.No other issues were identified during the product analysis.

• 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: 18284044
• Report Number: 2124215-2023-64583
• Device Sequence Number: 17689599
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• 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
• Report Date (Section B): 12/07/2023

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: 03/29/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0029311613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: EPTECH
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 55 KG