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

Model Number	83786
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil and the delivery wire were interlocked inside the introducer sheath.The main coil and the delivery wire were interlock.Twist lock was opened.The main coil was found stretched and the interlocking arm detached.Functional inspection revealed that the main coil was found detached inside the introducer sheath, for this reason the functional inspection could not be performed.Microscope inspection revealed that under magnification, it was possible to observe the interlocking arm detached.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the device was stuck in the microcatheter.The target lesion was located in the pelvic cavity.A 6mm x 20cm interlock.035 was selected for use.During the procedure, it was noted that the coil was stuck in the middle of the non-boston scientific microcatheter.The coil was withdrawn from the sheath and removed.The procedure was completed with another of the same device.No complications reported and the patient is stable.However, device investigations revealed that the interlocking arm was detached.

• Brand Name: INTERLOCK-35
• 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: 16163919
• Report Number: 2124215-2022-55652
• Device Sequence Number: 17905422
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: 08714729793021
• 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): 01/13/2023

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: 02/16/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0028892189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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: DELIVERY CATHETER-CORDIS 5F
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 75 KG