MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83786
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484); Stretched (1601); 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 eval by mfr: the device was received for analysis.The returned device matches with upn provided by the customer.Only a main coil was returned for this complaint.The delivery wire and introducer sheath did not return.The main coil was found kinked and stretched.No more damages were found.Microscopic inspection revealed the zap tip had a smooth surface.The interlocking arm was detached.Dimensional inspection was performed and the device met specification.
Event or Problem Description
Reportable based on device analysis completed on 07dec2021.It was reported that the coil prematurely deployed.A.035 interlock 2d 15mm x 40cm embolic coil was selected to embolize a splenic artery aneurysm.The coil was advanced into the middle of the catheter.There was friction advancing the coil.However, the coil prematurely deployed and became stretched.The coil and catheter were removed.A new coil and catheter were used to complete the procedure.There were no patient complications.However, device analysis revealed a detached interlocking arm.

• Brand Name: INTERLOCK-35
• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13014895
• Report Number: 2134265-2021-15721
• Device Sequence Number: 4976506
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: 08714729793144
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133208
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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: 10/20/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026218782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2020
• 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 Sex: Male