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

Model Number	83787
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 02-oct-2018.It was reported that coil could not be inserted in the hub of the catheter.The moderately tortuous target lesion was located in the left internal iliac artery (iia).A 6mm x 20cm interlock-35 coil was selected for use.During preparation, when trying to insert the coil into the 5f non bsc catheter, it was noted that there was resistance felt at the hub part and the coil could not be inserted.The device was removed together with the catheter.The procedure was completed with a different device.No patient complications were reported and the patient's status post procedure was stable.However, device analysis revealed that the interlocking arm was detached and it was not returned and proximal and distal fiber bundles were missing.Device evaluated by mfr: the device was returned for analysis.A main coil was returned for this complaint.The delivery wire and introducer sheath were not returned.The main coil was found kinked and stretched; the interlocking arm was detached and it was not returned.No more damages were found in the returned device.The delivery wire was not returned.The main coil zap tip has a smooth surface.The main coil was stretched and kinked; the interlocking arm was detached and it was not returned.The fiber bundles showed blood residues.Dimensional inspection revealed that the number of distal and proximal fiber bundles failed to meet specification.The zap tip outer diameter (od) and the primary coil od were within specification.

• 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: 8019503
• Report Number: 2134265-2018-62453
• Device Sequence Number: 1578685
• Product Code: KRD
• UDI-Device Identifier: 08714729793090
• UDI-Public: 08714729793090
• 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): 10/30/2018

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: 08/28/2020
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0021068169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1