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

Model Number	83779
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the pusher wire, the main coil and the introducer sheath were returned for product analysis.The introducer sheath was observed, and no damages were noted.The twist lock was found opened.The coil and pusher wire arms were not interlocked within the introducer sheath.The main coil was kinked and stretched.The pusher wire was observed, and no damages were noted.No more damages were found in the device.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was noted to be damaged.The main coil was stretched and kinked.Microscopic inspection of the pusher wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.Dimensional inspection of the pusher wire was performed and were within specifications.However, dimensional inspection of the main coil revealed missing fiber bundles due to a stretched section.The remaining measured dimensions were within specification.The functional test was unable to be performed due to the device condition.The pusher wire was unloaded and the coil remained inside the introducer sheath.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 30jun2022.It was reported that the coil could not be advanced in the microcatheter.A 22mmx60cm interlock coil was selected for use on the arteriovenous malformation.During the procedure, it was noted that the coil could not be advanced in the direxion microcatheter.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.However, device analysis revealed 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
• 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: 15086358
• Report Number: 2134265-2022-08035
• Device Sequence Number: 14727819
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: 08714729845324
• 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): 07/22/2022

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: 08/24/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026063589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 60 KG