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

Model Number	83786
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.A visual inspection revealed that a rotating hemostatic valve (rhv), a delivery wire, an introducer sheath and coil were returned for this complaint.The twist lock of the introducer sheath was found opened.The introducer sheath was inspected and no anomalies were noted.The delivery wire was inspected and no anomalies were noted.Visual and microscopic inspection were further completed.The coil was returned stretched near the interlocking arm end.The coil interlocking arm was found detached from the rest of the coil, in addition it was not returned.The dimensional inspection revealed that the dimensions that could be measured were within specification aside from the detached and not returned coil interlocking arm.
Event or Problem Description
Reportable based on device analysis completed on 09jul2019.It was reported that the premature deployment occurred.The target lesion was located in a moderately tortuous internal iliac artery.A 12mm x 20cm interlock-35 coil was selected for use in aortic aneurysm embolization procedure.During procedure, the coil prematurely detached in the microcatheter.The interlocking arm of the coil unlocked from the interlocking arm of the pusher wire.There were no patient complications reported.However, device analysis revealed that the coil interlocking arm was found detached from the rest of the coil.

• 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: 8837098
• Report Number: 2134265-2019-08819
• Device Sequence Number: 2755097
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• 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): 07/29/2019

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: 02/11/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0023334355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1