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

Model Number	83779
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 24may2024.It was reported that the device was difficult to coil-up, difficult to retract into the sheath, and was stretched.The patient presented with chirobrachialgia and was admitted to the hospital with arteriovenous fistula (avf).After locating the avf by angiography catheter, an 8mm x 20cm interlock was embolized with a torsional microcatheter.However, because the vessel was relatively thin, the coil was not easy to be wounded up, and was difficult to pull and retract into the sheath which caused the coil to be stretched.The microcatheter was withdrawn, and the procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.However, returned device analysis revealed a detached arm coil.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a visual inspection found that the main coil, the introducer sheath and the pusher wire were returned.It was observed that the main coil was bent and stretched at the coil arm, all primary coil and arm coil section, moreover the arm coil was detached.The functional inspection could not be performed due the main coil and the pusher wire are not interlocking.Based on the evidence, the reported issues could be confirmed due the device condition.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19578417
• Report Number: 2124215-2024-37895
• Device Sequence Number: 4056982
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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: 10/16/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030548989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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: 38 YR
• Patient Sex: Male
• Patient Weight: 58 KG