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); Premature Activation (1484); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter's tip upon removal.The target lesion was located at renal artery.An 8mm x 40cm and 8mm x 20cm interlock-35 coil were selected for use in a peripheral embolization of hemorrhage.The first 8mm x 40cm coil was introduced and worked fine.During the advancement and withdrawal of the catheter with the coil, the physician felt resistance when the second interlock 35 8mm x 20cm was introduced.Intermittent flushing was performed and the coil was advanced into the catheter.The coil was not moving or altering its position after about two thirds into the patient.The interlocking arm of the coil detached/unlocked from the interlocking arm of the pusher wire.The coil was unable to be pushed with another wire.The device was removed and pulled back along with the catheter from the patient though its proximal part was unwound and visually stretched.The deployed portion of the coil protruded from the catheter's tip upon removal.The procedure was completed with another 6mm x 20cm 2d interlock 35 coil successfully.No patient complications were reported.Patient was fine post procedure.

• 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: 10445171
• Report Number: 2134265-2020-11466
• Device Sequence Number: 2795126
• Product Code: KRD
• UDI-Device Identifier: 08714729793052
• UDI-Public: 08714729793052
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 08/24/2020

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: 02/04/2023
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0025160176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1