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

Model Number	83786
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil, the delivery wire and the introducer sheath were returned.The main coil and the delivery wire were not interlocked.Blood was noticed inside the introducer sheath.The main coil was kinked, stretched and detached at interlocking arm section.The functional test could not be performed due the main coil and the delivery wire were not interlocked.Under microscope, it was observed that the interlocking arm of the main coil was detached.Dimensional inspection of the delivery wire that could be measured were performed and were within specifications.Dimensional inspection of the main coil performed, and it was observed that the outer diameter (od) of the zap tip and primary coil were within specifications, however the coil arm od could not be measured due to the interlocking arm was detached.
Event or Problem Description
Reportable based on device analysis completed on 07dec2022.It was reported that device was unable to advance in the catheter and was stretched.A 6mmx20cm interlock-35 was selected for use.During the procedure, an 8mmx40cm coil was released first, followed by the device.However, the device could not be delivered.The physician tried for several times to move it gently, but it could not be pushed out.When the device was removed, it was stretched.The procedure was completed with another of the same the same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the interlocking arm of the main coil was detached.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16035170
• Report Number: 2124215-2022-53842
• Device Sequence Number: 7193968
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: 08714729793021
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2022

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: 12/15/2024
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0028570625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 47 KG