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

Model Number	83779
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The main coil, the pusher wire and the introducer sheath were returned.The introducer sheath was detached at proximal section.The main coil and the pusher wire were interlocked inside the introducer sheath.The pusher wire was kinked, stretched and broken at distal section.The main coil was kinked and stretched.No more damages were found.Functional inspection was performed and the pusher wire was advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck due its damage condition, it was pulled out backwards in order to release the main coil.Microscopic inspection was performed and it was confirmed that the introducer sheath was detached, and the pusher wire was broken at distal section.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 15jul2022.It was reported that the coil became stuck in the catheter.A 4mmx15cm interlock coil was selected for use on the mesenteric artery.During the procedure, it was noted that the coil became stuck in the middle of the catheter.The procedure was completed with another of same device.No complications were reported and the patient was stable post procedure.However, device analysis revealed that the pusher wire was broken.

• 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: 15202532
• Report Number: 2134265-2022-08314
• Device Sequence Number: 11303212
• Product Code: KRD
• UDI-Device Identifier: 08714729764960
• UDI-Public: 08714729764960
• 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): 08/10/2022

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: 01/17/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026818036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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: 66 KG