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

Model Number	83779
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the coil, pusher wire, and introducer sheath were returned for this complaint, also a valve was returned.The coil was inspected, and it was found kinked and severely stretched.The pusher wire was found kinked.No more damage was found.Functional inspection revealed that the pusher wire was advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck, due the stretched condition.It was necessary to cut the introducer sheath in order to release the main coil.Microscopic inspection of the main coil and pusher wire revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies were noted.Dimensional inspection of the pusher wire and main coil revealed the components were within specification except the number of fiber bundles, which were only 15 out of 30.
Event or Problem Description
Reportable based on device analysis completed on 22jul2021.It was reported that the coil could not be delivered and deployed.The target lesion was located in the ilium.A 14mm x 30cm interlock was selected for use.During the procedure, it was noted that the coil could not be delivered and deployed.The device was simply pulled out and the procedure was completed with a different device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that there were missing fiber bundles.

• 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: 12303049
• Report Number: 2134265-2021-10093
• Device Sequence Number: 14335810
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• 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): 08/10/2021

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: 12/20/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026657332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 75