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

Model Number	83786
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that coil protrusion occurred.The target lesion area was located in the mildly tortuous and mildly calcified internal iliac artery.A 4mm x 10cm interlock -35 coil was selected for use in a vascular embolization.During the procedure, early detachment occurred inside the microcatheter, the mail coil and delivery wire arm got separated.The device was removed together with the microcatheter.It was noted that the coil was protruded from the catheter tip upon removal.No patient complications were reported and the patient was good post procedure.
Additional Manufacturer Narrative
E1- initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual inspection revealed that only a main coil was returned for this complaint.The main coil was found kinked and stretched.The fiber bundles have blood residues.No more damages were found in the returned device.A microscopic and dimensional inspection revealed that the main coil was within its specification.
Event or Problem Description
It was reported that coil protrusion occurred.The target lesion area was located in the mildly tortuous and mildly calcified internal iliac artery.A 4mm x 10cm interlock -35 coil was selected for use in a vascular embolization.During the procedure, early detachment occurred inside the microcatheter, the mail coil and delivery wire arm got separated.The device was removed together with the microcatheter.It was noted that the coil was protruded from the catheter tip upon removal.No patient complications were reported and the patient was good post procedure.

• 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
• MDR Report Key: 9687380
• Report Number: 2134265-2020-01147
• Device Sequence Number: 10851502
• Product Code: KRD
• UDI-Device Identifier: 08714729792987
• UDI-Public: 08714729792987
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 02/20/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0023382952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: BREAKTHROUGH 2 MARKER; MICROCATHETER: BREAKTHROUGH 2 MARKER