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

Model Number	83779
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 02-oct-2018.It was reported that the coil remained inside the catheter.The target lesion was located in the splenic artery.A 5mm/15cm interlock was selected for use.During the procedure, the coils were loaded into the microcatheter; however, the coil became stuck at the hub and was not deployed.The coil was then completely removed from the patient's body without protrusion noted.The procedure was completed with another of same device.No complications were reported.However, device analysis revealed that the interlocking arm of the coil and zap tip was detached and not returned; also, there missing fiber bundles.It was further reported that the defective coil was detached and jammed inside the microcatheter and that the whole products were removed from the patient's body completely without additional intervention.The device was returned for analysis.A pusher wire, coil and introducer sheath were returned for this complaint.The coil and pusher wire arms were not interlocked, due to the interlocking arm of the coil was detached from the coil; the interlocking arm was returned together with the device.The introducer sheath was inspected and no visual defects were noted; the twist lock of the introducer sheath had been opened.Besides, residues of blood were noted within the introducer sheath and the coil fiber bundles.The pusher wire was inspected and no anomalies were noted.The coil was returned stretched in different points of it; besides the interlocking arm was detached.Due to the interlocking arm was detached, it was not possible to deliver the wire, besides, the main coil was stuck inside the introducer sheath, however, it was possible to be released.Microscopic inspection of the pusher wire and main coil was performed and revealed that the proximal end of the pusher wire has a smooth surface.The interlocking arm was inspected and no anomalies were noted.The zap tip was detached from the coil and it was not returned.The interlocking arm was detached from the coil, however, it was returned together with the device; it was in good condition.Dimensional inspection of the pusher wire that could be measured were performed and were within specifications.Coil dimensional inspection were performed and observed that the outer diameter (od) of the zap tip, od of primary coil were within specifications; however, there were 12 missing coil fiber bundles.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7974581
• Report Number: 2134265-2018-62022
• Device Sequence Number: 11182902
• Product Code: KRD
• UDI-Device Identifier: 08714729764984
• UDI-Public: 08714729764984
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: 07/01/2020
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0020954866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR