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

Model Number	83786
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by the manufacturer: the device was returned for analysis.Only a main coil was returned for this complaint; the introducer sheath and the delivery wire were not returned.The coil was found kinked and stretched.The zap tip has a smooth surface.The interlocking arm was detached and it was not returned.The dimensional inspection revealed that outer diameter of the zap tip, primary coil and distal and proximal fiber bundles were within it's specification.
Event or Problem Description
Reportable based on device analysis completed on 14oct2019.It was reported that the coil was deformed.The target lesion area was located in a moderately tortuous blood vessel.A 2d 8mmx20cm interlock-35 was selected for a gonadal vein embolization procedure.During the procedure, a deformity was noted on the coil and it was confirmed that the coil was frayed.The device was removed.The procedure was completed with a different device.No complications reported.However, device analysis revealed that the interlocking arm was detached and was not returned.

• 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: 9214736
• Report Number: 2134265-2019-12680
• Device Sequence Number: 2588715
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: 08714729793045
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K133208
• 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): 10/21/2019

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: 06/05/2021
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0022212218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/21/2019
• Patient Sequence Number: 1