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

Model Number	83779
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that only pusher wire was returned for this complaint.The pusher wire was inspected, and it was found kinked.No more damages were found in the device.Microscopic inspection of the pusher wire revealed that the proximal end has a smooth surface.The interlocking arm was inspected, and it was found detached (part not returned).Dimensional inspection of the pusher wire revealed that the components were within specification.
Event or Problem Description
Reportable based on device analysis completed on 29apr2021.It was reported that the coil did not form a basket shape.The target lesion was located in the renal artery.A 12mm x 30cm interlock was selected for use.During procedure, the microcatheter reached the target position.The first 14x30 coil reached the position and deployed.The 12x30 coil was then used; however, it was noted that the coil did not form a basket shape after it was pushed.The coil was pushed again, but it did not form a basket shape as well.The coil was withdrawn and the procedure was completed with another of same device.After that, the physician used a 10x30 and another 12x30 coil and completed the procedure.No patient complications were reported and patient was stable post procedure.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: 11850269
• Report Number: 2134265-2021-06069
• Device Sequence Number: 17085508
• Product Code: KRD
• UDI-Device Identifier: 08714729765059
• UDI-Public: 08714729765059
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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: 08/12/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022640931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 65