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

Model Number	83786
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 29feb2024.It was reported that the coil could not be advanced from the catheter.A 12mm x 40cm interlock-35 coil was selected for splenic artery embolization.During the course of the procedure, there was something wrong at the entrance of the delivery system and the coil could not be advanced any more.The coil was withdrawn from patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.However, device analysis revealed a detached arm coil.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual inspection was performed and it was observed that the main coil, the introducer sheath and the delivery wire were returned.It was observed that the main coil was bent and stretched at the coil arm, all primary coil and zap tip section.Also, the arm coil was detached.The original pouch was returned, and it was observed that the pouch information matches with the complaint information.The functional inspection could not be performed due to the main coil and the pusher wire are not interlocking.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.

• Brand Name: INTERLOCK-35
• 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: 18937623
• Report Number: 2124215-2024-13873
• Device Sequence Number: 15196431
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: 08714729792970
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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: 08/17/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029977736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: 63 YR
• Patient Sex: Male