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

Model Number	83787
Medical Device Problem Codes	Separation Failure (2547); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection observed that the main coil, the introducer sheath and the delivery sheath were returned.The main coil was bent and stretched at the primary coil section.Moreover, the arm coil was detached.Functional inspection could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection was performed, and the main coil's max zap tip outer diameter (od) and primary coil od passed the specification test.Based on the evidence, the reported allegations of main coil difficult to advance in catheter and failure to separate could not be confirmed; however, the physician used a non-bsc catheter.The use of other diagnostic catheters may result in an inability to deliver, deploy, or recapture the device.
Event or Problem Description
Reportable based on device analysis completed on 25nov2024.It was reported that the coil failed to deploy.The target lesion was located in the pelvic hemorrhage.After a successful embolization in the external iliac artery, the procedure continued, and a 10mm x 40cm interlock-35 cube coil was advanced along with non-boston scientific catheter.However, it was difficult to advance in the catheter at about halfway, and it could not be released.The device was replaced with another 10mm x 40cm interlock-35 coil, but the problem still occurred.The procedure was completed with a different device.No complications were reported, and the patient condition following procedure was stable however, returned device analysis revealed the arm coil was detached.

• 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: 20924932
• Report Number: 2124215-2024-77152
• Device Sequence Number: 12859611
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: 08714729795513
• 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): 12/13/2024

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 Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0032997542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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: Female