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

Model Number	83786
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device investigation completed on (b)(6) 2023.It was reported that the coil got stuck.The target lesion was located in the internal iliac artery.A 10mm x 40cm interlock-35 was selected for use.During the procedure, it was noted that the coil was stuck in the middle of the catheter and was stretched after withdrawal.The device was simply removed, and the procedure was completed with another of the same coil.No complications reported and the patient is stable.However, device analysis revealed that the main coil was detached at the coil arm section.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for evaluation.Visual and microscopic inspection revealed that the main coil, the pusher wire and the introducer sheath were returned for the analysis.It was observed that the main coil was bent, stretched and detached at the coil arm section, and it was stretched at the zap tip section.Additionally, the introducer was damage at the twist lock section.No more damages can be observed on the device.The functional test could not be performed due the pusher wire and the main coil are not interlocking.For dimensional inspection of the main coil, the outer diameter (od) of the zap tip and primary coil 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17623236
• Report Number: 2124215-2023-42096
• Device Sequence Number: 15339815
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: 08714729793168
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2023

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: 01/12/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0028676693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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: MICORCATHETER-5F CATHETER
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 65 KG