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

Model Number	83786
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.A delivery wire, main coil, hoop and introducer sheath were returned for this complaint.Besides, a rhv was returned.The coil and delivery wire arms were interlocked.The introducer sheath was inspected and no anomalies were noted, the twist lock had been opened; however, blood residues were found inside.The main coil fiber bundles had blood residues.The delivery wire was advanced through the introducer sheath, but it was not possible to continue advancing it due to the main coil was stuck; it was necessary to cut the sheath in order to release the main coil.Microscopic inspection of the delivery wire was performed and revealed that the proximal end has a smooth surface.The delivery wire interlocking arm was found kinked.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The main coil was stretched near the interlocking arm and the interlocking arm was detached.Dimensional inspection of the delivery wire that could be measure were performed and were within specification.Dimensional inspection of the no.Of proximal fiber bundles, outer diameter (od) of the zap tip and od of the primary coil were performed and were specifications.However, dimensional inspection of the no.Of distal fiber bundles revealed lacking fiber bundle.
Event or Problem Description
Reportable based on device analysis completed on 23dec2019.It was reported that the coil was stuck in the microcatheter.The target lesion was in a severely tortuous right internal iliac artery.A 4mmx10cm interlock-35 was selected for use.During the procedure, it was noted that the coil was stuck in the microcatheter and the procedure was not completed.No patient complications were reported.However, device analysis revealed detached interlocking arm and lacking coil fiber bundle.

• 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: 9581504
• Report Number: 2134265-2019-16733
• Device Sequence Number: 3012219
• 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
• Report Date (Section B): 01/13/2020

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: 05/15/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0023800957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1