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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83779
Device Problems Break (1069); Stretched (1601)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/05/2024
Event Type  Injury  
Event Description
It was reported that the coil broke and was partially recovered.The target lesion was located in the left internal iliac artery.A 10mm x 50cm interlock was selected for embolization of the superior and inferior gluteal artery.The coil was successfully implanted in the left internal iliac artery.Upon removal of the microcatheter, it was noted that there was a marker-like object observed in the non-boston scientific guide catheter near the entrance area.The coil was considered to have been stretched; therefore, the coil was recovered.During imaging, two marker-like objects were observed.The coil was slowly pulled out and the marker-like object disappeared.The procedure was completed with another renegade with the same specs.No patient complications were reported.
 
Event Description
It was reported that the coil broke and was partially recovered.The target lesion was located in the left internal iliac artery.A 10mm x 50cm interlock was selected for embolization of the superior and inferior gluteal artery.The coil was successfully implanted in the left internal iliac artery.Upon removal of the microcatheter, it was noted that there was a marker-like object observed in the non-boston scientific guide catheter near the entrance area.The coil was considered to have been stretched; therefore, the coil was recovered.During imaging, two marker-like objects were observed.The coil was slowly pulled out and the marker-like object disappeared.The procedure was completed with another renegade with the same specs.No patient complications were reported.
 
Manufacturer Narrative
H6 - impact code updated.
 
Manufacturer Narrative
H6 - impact code updated.Device evaluated by mfr: only the coil of the pusher wire was returned.It was observed that this part completely detached of the pusher wire and also was stretched.The functional could not be performed due no complete device was returned.The dimensional could not be performed due no complete device was returned.No other issues were identified with the device and no patient complications were reported.
 
Event Description
It was reported that the coil broke and was partially recovered.The target lesion was located in the left internal iliac artery.A 10mm x 50cm interlock was selected for embolization of the superior and inferior gluteal artery.The coil was successfully implanted in the left internal iliac artery.Upon removal of the microcatheter, it was noted that there was a marker-like object observed in the non-boston scientific guide catheter near the entrance area.The coil was considered to have been stretched; therefore, the coil was recovered.During imaging, two marker-like objects were observed.The coil was slowly pulled out and the marker-like object disappeared.The procedure was completed with another renegade with the same specs.No patient complications were reported.It was further reported that the coil was fully deployed.The coil was partially recovered.The recovered coil was unraveled, it was thought that the broken coil was probably left behind, and it was thought that it might remain in the body.If the recovered coil was the full length of the coil, it had been recovered all, but it was not clear whether the coil was broken or if the entire length had been recovered.It was not sure because the coil was stretched.
 
Event Description
It was reported that the coil broke and was partially recovered.The target lesion was located in the left internal iliac artery.A 10mm x 50cm interlock was selected for embolization of the superior and inferior gluteal artery.The coil was successfully implanted in the left internal iliac artery.Upon removal of the microcatheter, it was noted that there was a marker-like object observed in the non-boston scientific guide catheter near the entrance area.The coil was considered to have been stretched; therefore, the coil was recovered.During imaging, two marker-like objects were observed.The coil was slowly pulled out and the marker-like object disappeared.The procedure was completed with another renegade with the same specs.No patient complications were reported.It was further reported that the coil was fully deployed.The coil was partially recovered.The recovered coil was unraveled, it was thought that the broken coil was probably left behind, and it was thought that it might remain in the body.If the recovered coil was the full length of the coil, it had been recovered all, but it was not clear whether the coil was broken or if the entire length had been recovered.It was not sure because the coil was stretched.
 
Manufacturer Narrative
Device evaluated by mfr: only the coil of the pusher wire was returned.It was observed that this part completely detached from the pusher wire and also was stretched.Functional testing and dimensional inspection could not be performed since the complete device was not returned.A picture was provided, and it was possible to observe that the coil was stretched.No other issues were identified with the device.
 
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Brand Name
INTERLOCK
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 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 Key18634630
MDR Text Key334492121
Report Number2124215-2024-02002
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729845287
UDI-Public08714729845287
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K132578
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,Followup,Followup
Report Date 04/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0032613239
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE CATHETER: 4FR OPTIFLUSHJR4.0; GUIDE CATHETER: 4FR OPTIFLUSHJR4.0; GUIDE CATHETER: 4FR OPTIFLUSHJR4.0; GUIDE CATHETER: 4FR OPTIFLUSHJR4.0
Patient Outcome(s) Required Intervention;
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