MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83787
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 05oct2023.It was reported that the coil was stuck.The target lesion was in the lower limb.A 15mm x 25cm interlock-35 was selected for use.During the procedure, it was noted that coil was stuck in the middle of the catheter.The coil and the catheter were removed together, and the procedure was completed with another of the same device.No complications reported and the patient is stable.However, device investigations revealed that the main coil was detached at the coil arm section.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.For visual inspection, it is possible to observed blood inside the introducer.Additionally, it was observed the main coil was stretched, detached and bent at coil arm section and it was observed the main coil bent and stretched 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.For microscope inspection, it was observed that the main coil was stretched, detached and bent at coil arm section.The functional inspection could not be performed; due the main coil and the introducer are interlocking.Dimensional inspection revealed that the outer diameter of the zap tip, primary coil and coil arm were within the specification.

• Brand Name: INTERLOCK-35
• 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 CORK LIMITED; 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: 17998824
• Report Number: 2124215-2023-55487
• Device Sequence Number: 6681150
• Product Code: KRD
• UDI-Device Identifier: 08714729793113
• UDI-Public: 08714729793113
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133208
• 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): 10/24/2023

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: 03/30/2025
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0029146041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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- CORDIS 5F CATHETER.
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 75 KG