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

Model Number	83779
Medical Device Problem Codes	Stretched (1601); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
Reportable based on analysis completed on 9-nov-2018.It was reported that the device did not coil up successfully and got elongated when it was pulled and pushed.A stenosed target lesion was located at severely tortuous splenorenal vein.A 20mm x 50cm interlock was selected for use for the shunt embolization procedure.During the procedure, it was reported that the device did not coil up successfully and became elongated when it was pulled and pushed.The device was removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed missing coil fiber bundles.Device evaluated by mfr: the coil was returned; the pusher wire and the introducer sheath were not returned.The visual inspection showed that the coil was returned stretched and kinked.Microscopic inspection of the main coil showed that the zap tip has a smooth surface, the main coil was stretched and kinked, and some coil fiber bundles were missing.The interlocking arm was inspected and no anomalies were noted.The dimensional inspection of the zap tip outer diameter (od) and the primary coil od were within specification.The number of fiber bundles failed dimensional inspection as there were 18 fiber bundles instead of 20.

• 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: 8111824
• Report Number: 2134265-2018-63308
• Device Sequence Number: 16622748
• Product Code: KRD
• UDI-Device Identifier: 08714729845317
• UDI-Public: 08714729845317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• 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): 11/28/2018

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: 06/03/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022335298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1