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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter tip upon removal.The target lesion was in the splenic artery.A 14mm x 30cm pe f-idc interlock was selected for use.During a splenic aneurysm embolization procedure, after three 14mmx30cm 18 system coils were deployed this device was used.However, it was noted that this device could not be pushed at the distal end about 6-10cm from the tip of the microcatheter and protruded from the catheter tip upon removal.The procedure was completed with another of the same device.No complications reported and the patient is stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The main coil, the introducer sheath and the pusher wire were returned for analysis.It was observed that the main coil was bent and stretched at the coil arm section.A part of the original box was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.The functional test could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection of the main coil revealed that the outer diameter of the coil arm, zap tip and the primary coil were within specification.
Event or Problem Description
It was reported that the coil protruded from the catheter tip upon removal.The target lesion was in the splenic artery.A 14mm x 30cm pe f-idc interlock was selected for use.During a splenic aneurysm embolization procedure, after three 14mmx30cm 18 system coils were deployed this device was used.However, it was noted that this device could not be pushed at the distal end about 6-10cm from the tip of the microcatheter and protruded from the catheter tip upon removal.The procedure was completed with another of the same device.No complications reported and the patient is stable.

• 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: 18141935
• Report Number: 2124215-2023-61716
• Device Sequence Number: 20438134
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• 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,Followup
• Report Date (Section B): 01/08/2024

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: 12/25/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030920820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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: MICROCATHETER-ASAHI 0.021; MICROCATHETER-ASAHI 0.021
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 92 KG