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

Model Number	83779
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Visual inspection was performed, and it was observed that the main coil and the pusher wire were not interlocked.The pusher wire and the introducer sheath were returned.The twist lock was opened.The introducer sheath was detached at 17.4 cm of the proximal section.The pusher wire was detached at 20.2 cm of distal section, and it was kinked and stretched.The main coil was kinked and stretched.Microscopic inspection of the device was performed and revealed that the introducer sheath was detached at 17.4 cm of the proximal section and the pusher wire was detached at 20.2 cm of distal section.Dimensional inspection of the pusher wire was performed and revealed that the distal solder joint outer diameter (o.D), mid solder joint o.D, distal tfe o.D, and proximal tfe o.D were within specification.Dimensional inspection of the main coil was performed and revealed that the number of the fiber bundles do not meet the specification.The remaining dimensions that can be measured were within specification.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 06oct2022.It was reported that the coil could not be delivered.A 10mm x 20cm interlock coil was selected for use in a splenic artery aneurysm.During the procedure, the coil could not be delivered.The issue could not be resolved despite repeat flushing and exchanging the catheter.The procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.However, device analysis revealed a detached pusher wire and missing coil 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15676548
• Report Number: 2124215-2022-42544
• Device Sequence Number: 6421221
• Product Code: KRD
• UDI-Device Identifier: 08714729765028
• UDI-Public: 08714729765028
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2022

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: 09/06/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0028164265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 50 KG