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

Model Number	83786
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a coil disintegration occurred.A 15mmx20cm interlock-35 was selected for use.During the procedure, when the interlock passed to the left gonadal vein, it was noted that the coil disintegrated.The procedure was completed with another of the same device.No complications reported and patient was stable after the procedure.
Event or Problem Description
It was reported that a coil disintegration occurred.A 15mmx20cm interlock-35 was selected for use.During the procedure, when the interlock passed to the left gonadal vein, it was noted that the coil disintegrated.The procedure was completed with another of the same device.No complications reported and patient was stable after the procedure.It was further reported that the coil was frayed.The coil was implanted and remained in the patient's body.
Additional Manufacturer Narrative
Initial reporter address 1:(b)(6).

• 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: 8934573
• Report Number: 2134265-2019-10224
• Device Sequence Number: 11262737
• Product Code: KRD
• UDI-Device Identifier: 08714729793120
• UDI-Public: 08714729793120
• 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,Followup
• Report Date (Section B): 10/08/2019

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: 04/03/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0023592147
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR