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

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 09nov2021.It was reported that the coil was stuck.The target lesion was located in the splenic artery.A 10mm x 50cm interlock was selected for use for the embolization procedure.During the procedure, it was noted that the coil got stuck in the delivery microcatheter (.028 inner diameter).The procedure was completed with a non-bsc coil.No patient complications were reported.However, device analysis revealed that the zap tip and interlocking arm were detached, and the fiber bundles were missing.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A pusher wire, introducer sheath and main coil were returned analysis.The coil and pusher wire arms were not interlocked within the introducer sheath.A significant amount of blood was found inside the introducer sheath.The coil was inspected, and it was found kinked and severely stretched.The pusher wire was inspected, and it was kinked.No more damages were found in the returned device.Microscopic inspection of the pusher wire was performed and observed that the proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Microscopic inspection of the main coil was performed and observed that the zap tip is detached.The interlocking arm was inspected, and it was detached.Dimensional inspection of the pusher wire that could be measured were performed and were within specifications.Dimensional inspection of the main coil that could be measured were performed and observed that the outer diameter (od) of the zap tip and primary coil were within specifications.However, there were lacking coil fiber bundles.12 fiber bundles were present (specification is 20).

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12922909
• Report Number: 2134265-2021-14694
• Device Sequence Number: 12166300
• Product Code: KRD
• UDI-Device Identifier: 08714729845287
• UDI-Public: 08714729845287
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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: 04/13/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027315188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown