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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was stuck on the microcatheter tip upon withdrawal.A 3mmx6cm interlock was used together with a renegade catheter in a pulmonary embolism.During the procedure, it was noted that the pusher wire arm could not be released leading to the coil being stuck in the tip of the microcatheter when withdrawn for a period of time.The physician was finally able to pull the coil into the renegade and it was simply removed from the patient with the coil inside.The procedure was completed with another of the same device.No complications reported and the patient is stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A pusher wire and introducer sheath were returned for this complaint.The main coil was not returned.The twist lock of the introducer sheath had been opened.The introducer sheath was inspected and no anomalies were noted.The pusher wire was inspected and no anomalies were noted.No damages were found in the device.The pusher wire was advanced through the introducer sheath without problems, no resistance was felt.Microscopic inspection of the pusher wire revealed that the proximal end has a smooth surface.The interlocking arm was inspected and no anomalies were noted.Dimensional inspection of the pusher wire that could be measure were performed and were within specification.
Event or Problem Description
It was reported that the coil was stuck on the microcatheter tip upon withdrawal.A 3mmx6cm interlock was used together with a renegade catheter in a pulmonary embolism.During the procedure, it was noted that the pusher wire arm could not be released leading to the coil being stuck in the tip of the microcatheter when withdrawn for a period of time.The physician was finally able to pull the coil into the renegade and it was simply removed from the patient with the coil inside.The procedure was completed with another of the same device.No complications reported and the patient is stable.

• 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: 8944051
• Report Number: 2134265-2019-10351
• Device Sequence Number: 11402929
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 10/01/2019

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: 07/16/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022521972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR