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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the coil protruded from the catheter tip.Vascular access was obtained via the right femoral approach.The target lesion was located in the moderately tortuous and moderately calcified left internal iliac artery.A 10mmx20cm interlock was selected for use.During procedure, two 14mmx30cm and two 12mmx30cm coils were placed after the lesion was accessed.Subsequently, the 10mmx20cm coil was advanced and slightly extended from the micro catheter.The extended coil from the catheter could not be pulled in attempt to perform recoil and coil was judged to have been detached.Both coil and microcatheter were removed together from the patient's body.However, the distal end of the coil was noted to be slightly protruding from the microcatheter tip upon removal.A non-bsc microcatheter was used to access again the lesion and placed three 10mmx20cm, on 8mmx20cm and three 6mmx20cm, and completed the prcoedure.No complications reported and patient was good.

• 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: 10288721
• Report Number: 2134265-2020-09463
• Device Sequence Number: 3462389
• Product Code: KRD
• UDI-Device Identifier: 08714729765028
• UDI-Public: 08714729765028
• 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): 07/17/2020

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: 09/07/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022759731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER- 5FR IMPRESS; GUIDEWIRE- MEISTER; IMAGING CATHETER- LIGHTHOUSE; INTRODUCER SHEATH -5F DESTINATION