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

Model Number	83786
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 20dec2023.It was reported that the coil was stuck in the catheter.The patient was being treated for abdominal aortic aneurysm and underwent bilateral intra-iliac embolization.A 12mm x 40cm interlock-35 was selected for use.During the procedure, the interlock was advanced with a non-boston scientific angiographic catheter.Before advancing the device has been flushed by heparin saline, the position should be adjusted during advancing, however it was found that the device was stuck in middle part of the catheter, and the coil were released in the angiographic catheter.The coil was removed with the catheter and the procedure was completed with another of the same device.There were no complications reported and the patient was stable.However, device investigations revealed that the main coil was detached at the zap tip section, primary coil and arm coil section.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.It was observed that the main coil was inside a non boston scientific catheter.The main coil was found to be bent/kinked, detached, and stretched at the zap tip, primary coil, and arm coil sections.No additional damages were observed.Functional evaluation could not be performed due the main coil and the pusher wire were not interlocking.Dimensional inspection of the main coil revealed that the outer diameter of the zap tip, primary coil and the coil arm were within specification.The reported clinical observation of unable to advance in catheter was confirmed due to the non boston scientific catheter used.The reported clinical observation of premature deployment was unable to be confirmed since the mail coil could not be functionally evaluated to confirm this observation.
Event or Problem Description
Reportable based on device analysis completed on 20dec2023.It was reported that the coil was stuck in the catheter.The patient was being treated for abdominal aortic aneurysm and underwent bilateral intra-iliac embolization.A 12mm x 40cm interlock-35 was selected for use.During the procedure, the interlock was advanced with a non-boston scientific angiographic catheter.Before advancing the device has been flushed by heparin saline, the position should be adjusted during advancing, however it was found that the device was stuck in middle part of the catheter, and the coil were released in the angiographic catheter.The coil was removed with the catheter and the procedure was completed with another of the same device.There were no complications reported and the patient was stable.However, device investigations revealed that the main coil was detached at the zap tip section, primary coil and arm coil section.
Additional Manufacturer Narrative
Updated field: h6.Evaluation conclusion codes- from failure to follow instructions to unintended use error caused or contributed to event.Device evaluated by mfr: the device was returned for evaluation.It was observed that the main coil was inside a non boston scientific catheter.The main coil was found to be bent/kinked, detached, and stretched at the zap tip, primary coil, and arm coil sections.No additional damages were observed.Functional evaluation could not be performed due the main coil and the pusher wire were not interlocking.Dimensional inspection of the main coil revealed that the outer diameter of the zap tip, primary coil and the coil arm were within specification.The reported clinical observation of unable to advance in catheter was confirmed due to the non boston scientific catheter used.The reported clinical observation of premature deployment was unable to be confirmed since the mail coil could not be functionally evaluated to confirm this observation.

• 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: 18486589
• Report Number: 2124215-2023-73428
• Device Sequence Number: 14368960
• 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,Followup
• Report Date (Section B): 02/20/2024

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: 07/12/2026
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0032004776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: COOK 5F ANGIOGRAPHIC CATHETER; COOK 5F ANGIOGRAPHIC CATHETER
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 63 KG