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

Model Number	83786
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the end of the coil had no interlocking arm.The target location was in the left internal iliac artery.A 10mm x 40cm interlock-35 was the first coil advanced for embolization of the iliac aneurysm.During the procedure, the coil was detached while it was being advanced, and it was observed that the end of the coil had no interlocking arms.A second coil, a 12mm x 40cm interlock-35 was attempted to be used, but it could not be pushed out of the tip of the protective sheath even after multiple attempts.The coil was found to be stretched.Subsequently, an 8mm x 40mm coil was used and advanced successfully.No complications were reported, and the patient was stable.
Event or Problem Description
It was reported that the end of the coil had no interlocking arm.The target location was in the left internal iliac artery.A 10mm x 40cm interlock-35 was the first coil advanced for embolization of the iliac aneurysm.During the procedure, the coil was detached while it was being advanced, and it was observed that the end of the coil had no interlocking arms.A second coil, a 12mm x 40cm interlock-35 was attempted to be used, but it could not be pushed out of the tip of the protective sheath even after multiple attempts.The coil was found to be stretched.Subsequently, an 8mm x 40mm coil was used and advanced successfully.No complications were reported, and the patient was stable.It was further reported that the target lesion was in the right iliac artery.When the 10mm x 40cm interlock-35 was removed from the pouch, the coil and the pusher wire arms were interlocked in the introducer sheath.The detached interlocking arm were found inside the catheter and was not left inside the patient.Both devices were removed from the body by the pusher wire arms.
Additional Manufacturer Narrative
Device evaluated by mfr.: the main coil, the introducer sheath and the delivery wire were returned.Visual inspection revealed that the main coil was bent and stretched at the zap tip and primary coil section, moreover, the coil arm was detached.Microscopic inspection revealed the main coil was bent, stretched and detached.Functional inspection could not be performed due the main coil and the pusher wire are not interlocking.The dimensions for the zap tip outer diameter (od) and the primary coil od were inspected and were within specification.
Event or Problem Description
It was reported that the end of the coil had no interlocking arm.The target location was in the left internal iliac artery.A 10mm x 40cm interlock-35 was the first coil advanced for embolization of the iliac aneurysm.During the procedure, the coil was detached while it was being advanced, and it was observed that the end of the coil had no interlocking arms.A second coil, a 12mm x 40cm interlock-35 was attempted to be used, but it could not be pushed out of the tip of the protective sheath even after multiple attempts.The coil was found to be stretched.Subsequently, an 8mm x 40mm coil was used and advanced successfully.No complications were reported, and the patient was stable.It was further reported that the target lesion was in the right iliac artery.When the 10mm x 40cm interlock-35 was removed from the pouch, the coil and the pusher wire arms were interlocked in the introducer sheath.The detached interlocking arm were found inside the catheter and was not left inside the patient.Both devices were removed from the body by the pusher wire arms.

• 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: 19540893
• Report Number: 2124215-2024-35088
• Device Sequence Number: 7604583
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: 08714729793168
• 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,Followup
• Report Date (Section B): 09/26/2024

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: 09/18/2026
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0032456708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 09/03/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/09/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 73 KG