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	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that only a main coil was returned for this complaint.The coil was kinked and stretched.Microscopic inspection revealed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Dimensional inspection revealed that the components were within specifications except the number of fiber bundles, which were only 10 out of 30.
Event or Problem Description
Reportable based on device analysis completed on 23 jul 2020.It was reported that the coil was unable to cross the lesion.The heavy stenosed target lesion was located in the very calcified internal iliac artery.A 12mm x 30cm interlock coil was selected for use.During procedure, it was noted that the coil was unable to cross the lesion.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that there were missing 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: 10328402
• Report Number: 2134265-2020-09978
• Device Sequence Number: 2890041
• Product Code: KRD
• UDI-Device Identifier: 08714729765059
• UDI-Public: 08714729765059
• 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): 07/27/2020

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: 09/16/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024611162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR