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

Model Number	83787
Medical Device Problem Codes	Failure to Advance (2524); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 26sep2024.It was reported that a coil advancing, and deployment issue occurred.A 15mm x 40cm interlock-35 coil was selected for splenic aneurysm implantation.However, during the procedure, it was noted that the coil could not be detached and pushed out in the catheter.The device was removed and the procedure was completed with another of the same device.No patient complications were reported, and the patient was stable post-procedure.However, device analysis revealed the zap tip, and the arm coil were detached.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual and microscopic inspection were performed, and it was observed that the main coil was stretched at all primary coil section, the zap tip and the arm coil were detached, moreover the delivery sheath was stretched and bent at distal section.The functional inspection could not be performed due the main coil and the pusher wire are not interlocking.Dimensional testing cannot be performed due to the condition of the device return as it is separated at the zap tip, arm coil and the entire primary coil is fully stretched.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: 20516261
• Report Number: 2124215-2024-64615
• Device Sequence Number: 8497145
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: 08714729795438
• 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): 10/23/2024

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: 06/13/2026
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0031816172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER: CORDIS 5F.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 78 KG