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

Model Number	83779
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection.A pusher wire and mail coil were returned for this complaint.Introducer sheath was not returned.The pusher wire and coil were not interlocked, coil returned separated.Main coil was found kinked and stretched.The pusher wire was inspected, and it was kinked no more damages were found in the device.Microscopic inspection.Pusher wire, the proximal end has a smooth surface.The interlocking arm was inspected, and it was detached.Main coil, the zap tip has a smooth surface.The interlocking arm was inspected, and it was detached.Dimensional inspection for both pusher wire and main coil specification was performed and passed.
Event or Problem Description
Reportable based on device analysis completed on 11nov2021.It was reported that the coil could not be delivered.The target lesion was located in the splenic artery.A 18mm x 50cm 2d interlock coil was selected for use.During the procedure, the coil could be delivered even after multiple flushing.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.However, returned device analysis revealed that the interlocking arm was detached.

• 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: 12911529
• Report Number: 2134265-2021-14660
• Device Sequence Number: 4956263
• Product Code: KRD
• UDI-Device Identifier: 08714729845300
• UDI-Public: 08714729845300
• 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): 12/01/2021

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: 01/17/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026818072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/01/2021
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 60 KG