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

Model Number	83787
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
Reportable based on additional information received on 11-oct-2018.It was reported that the coil was stuck in the catheters tip during removal.The target lesion was located in the severely tortuous internal iliac artery (iia).A 15mm x 25cm interlock-35 coil was selected for use for the abdominal aortic aneurysm procedure.During the procedure, it was noted that the coil came out from the unspecified angiographic catheter and it coiled up two times.However, after that, the physician couldn't roll the whole coil well and the coil didn't come out from the catheter completely.The coil was therefore simply removed, but in the process it was noticed that the coil became stuck in the catheters tip and there was coil protrusion noted at the tip of the catheter upon removal.The procedure was completed with different device.No patient complications were reported.

• 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: 8025851
• Report Number: 2134265-2018-62261
• Device Sequence Number: 19131370
• Product Code: KRD
• UDI-Device Identifier: 08714729793113
• UDI-Public: 08714729793113
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: 04/30/2021
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0022061113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1