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

Model Number	83779
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual inspection revealed that only the pusher wire was returned for this compliant.The main coil and introducer sheath was not returned.The pusher wire was inspected and was found kinked in several sections.The interlocking arm was inspected and was found detached.A microscopic and dimensional inspection revealed that the main coil was not returned.The distal solder joint (od), mid solder joint o.D, distal tfe o.D, and proximal tfe o.D were within its specification.
Event or Problem Description
Reportable based on device analysis completed on 18feb2020.It was reported that the coil could not be detached and was found stretched.The target lesion was located in the left renal artery.A 3mm x 12cm interlock coil was selected for use in a percutaneous arteriography and embolization.The patient was admitted due to bleeding in renal artery trauma.During the preparation, the physician pushed the wire repeatedly out of the micro catheter, however, the coil could not detach.Subsequently, the physician removed the 3*12 coil outside the body and found out that the coil was stretched and cannot be used.However, it was further reported that continous flushing was being use and was performed before introduction of the coil in a hand injection.The procedure was completed with another of same device.No patient complications were reported and patient status was stable.However, device analysis revealed that the interlocking arm was detached.

• 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: 9745158
• Report Number: 2134265-2020-01925
• Device Sequence Number: 2483346
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: 08714729764946
• 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
• Report Date (Section B): 02/24/2020

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: 07/28/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022574562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 62