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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83786
Device Problems Entrapment of Device (1212); Failure to Advance (2524); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2023
Event Type  malfunction  
Event Description
It was reported that the coil protruded in the catheter's tip upon removal.A 10mm x 40cm and 15mm x 40cm interlock-35 coils were selected for ventral aorta branch covered stent implantation, left and right internal iliac artery embolization, and aortography.During the procedure, a 15mmx40cm coil was pushed to the neck of the main abdominal tumor, but it could not be further advanced, which could go back but not forward.Embolization could not be completed with the internal iliac artery, so a 10mmx40cm was used to superselect the right iliac through the left femoral artery.However, the first 10cm were smooth, but the position was not suitable and could not be advanced after multiple attempts.Furthermore, when the coils were removed from the patient's body, it was noted that the coils protruded from the tip of the catheter.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The main coil, the introducer and the pusher wire returned for the analysis.Additionally, it was observed the main coil was stretched, detached and bent at the coil arm section and it was observed stretched at the zap tip section.And the introducer was observed damage at distal section and detached at the twist lock section.No more damages can be observed on the device during visual inspection.Under the microscope it was observed that the main coil was stretched, detached and bent at the coil arm section and it was observed stretched at the zap tip section.The introducer was observed damage at distal section and detached at the twist lock section.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 the components were within specifications.No other issues were identified during the product analysis.
 
Event Description
It was reported that the coil protruded in the catheter's tip upon removal.A 10mm x 40cm and 15mm x 40cm interlock-35 coils were selected for ventral aorta branch covered stent implantation, left and right internal iliac artery embolization, and aortography.During the procedure, a 15mmx40cm coil was pushed to the neck of the main abdominal tumor, but it could not be further advanced, which could go back but not forward.Embolization could not be completed with the internal iliac artery, so a 10mmx40cm was used to superselect the right iliac through the left femoral artery.However, the first 10cm were smooth, but the position was not suitable and could not be advanced after multiple attempts.Furthermore, when the coils were removed from the patient's body, it was noted that the coils protruded from the tip of the catheter.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.
 
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Brand Name
INTERLOCK-35
Type of Device
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
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 Key17480786
MDR Text Key320692135
Report Number2124215-2023-41644
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729793168
UDI-Public08714729793168
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K133208
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/02/2023
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
Device Operator Health Professional
Device Model Number83786
Device Catalogue Number83786
Device Lot Number0030383203
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/12/2023
Initial Date FDA Received08/08/2023
Supplement Dates Manufacturer Received09/12/2023
Supplement Dates FDA Received10/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age72 YR
Patient SexMale
Patient Weight50 KG
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