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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); Difficult to Insert (1316); Premature Activation (1484); Failure to Advance (2524)
Patient Problems Hematoma (1884); Foreign Body In Patient (2687); Vascular Dissection (3160); Thrombosis/Thrombus (4440)
Event Date 05/16/2022
Event Type  Injury  
Event Description
It was reported that the coil prematurely deployed and broke.An interlock 18 10mm x 30cm coil was selected for use in the embolization of two coronary aneurysms in the left anterior descending artery (lad) in moderately tortuous anatomy.A guide catheter was used to reach the lad, and a direxion microcatheter was then used to attempt access more selectively, but it was not successful.Therefore, a non-boston scientific microcatheter was used to reach the location of the aneurysms.Gaining access was difficult and took approximately two hours.Once reached, the physician decided they did not want to lose microcatheter position to exchange for direxion.The interlock coil was inserted into the non-boston scientific microcatheter, which resulted in some resistance when the interlocking arms passed through the hub of the catheter.The coil was forced through, past the point of resistance.The coil tracked smoothly through the microcatheter and was positioned within the aneurysm.Upon deployment, the first 25cm of the coil deployed successfully within the aneurysm, however the last portion failed to deploy, and when the coil was retracted to retrieve it into the microcatheter, it was noticed that the interlocking mechanism had prematurely detached within the microcatheter.The wire was therefore retrievable, but the coil was stuck, partially deployed and unable to be flushed or pushed to full deployment.Attempts to do so resulted in the dissection of the circumflex artery, clotting in the lad and fragments of the coil, which unraveled upon retrieval attempts with a snare.The coil was partially removed through the microcatheter; some of the coil had to be left inside the patient extending from the lad into the aorta.The patient was untreated for both aneurysms, required stenting of the circumflex artery and will require anticoagulants for 6 months before being considered for further treatment.However, the patient was stable.
 
Event Description
It was reported that the coil prematurely deployed and broke.An interlock 18 10mm x 30cm coil was selected for use in the embolization of two coronary aneurysms in the left anterior descending artery (lad) in moderately tortuous anatomy.A guide catheter was used to reach the lad, and a direxion microcatheter was then used to attempt access more selectively, but it was not successful.Therefore, a non-boston scientific microcatheter was used to reach the location of the aneurysms.Gaining access was difficult and took approximately two hours.Once reached, the physician decided they did not want to lose microcatheter position to exchange for direxion.The interlock coil was inserted into the non-boston scientific microcatheter, which resulted in some resistance when the interlocking arms passed through the hub of the catheter.The coil was forced through, past the point of resistance.The coil tracked smoothly through the microcatheter and was positioned within the aneurysm.Upon deployment, the first 25cm of the coil deployed successfully within the aneurysm, however the last portion failed to deploy, and when the coil was retracted to retrieve it into the microcatheter, it was noticed that the interlocking mechanism had prematurely detached within the microcatheter.The wire was therefore retrievable, but the coil was stuck, partially deployed and unable to be flushed or pushed to full deployment.Attempts to do so resulted in the dissection of the circumflex artery, clotting in the lad and fragments of the coil, which unraveled upon retrieval attempts with a snare.The coil was partially removed through the microcatheter; some of the coil had to be left inside the patient extending from the lad into the aorta.The patient was untreated for both aneurysms, required stenting of the circumflex artery and will require anticoagulants for 6 months before being considered for further treatment.However, the patient was stable.
 
Manufacturer Narrative
Correction: added device code to h6.
 
Manufacturer Narrative
Correction to h6 patient codes.
 
Event Description
It was reported that the coil prematurely deployed and broke.An interlock 18 10mm x 30cm coil was selected for use in the embolization of two coronary aneurysms in the left anterior descending artery (lad) in moderately tortuous anatomy.A guide catheter was used to reach the lad, and a direxion microcatheter was then used to attempt access more selectively, but it was not successful.Therefore, a non-boston scientific microcatheter was used to reach the location of the aneurysms.Gaining access was difficult and took approximately two hours.Once reached, the physician decided they did not want to lose microcatheter position to exchange for direxion.The interlock coil was inserted into the non-boston scientific microcatheter, which resulted in some resistance when the interlocking arms passed through the hub of the catheter.The coil was forced through, past the point of resistance.The coil tracked smoothly through the microcatheter and was positioned within the aneurysm.Upon deployment, the first 25cm of the coil deployed successfully within the aneurysm, however the last portion failed to deploy, and when the coil was retracted to retrieve it into the microcatheter, it was noticed that the interlocking mechanism had prematurely detached within the microcatheter.The wire was therefore retrievable, but the coil was stuck, partially deployed and unable to be flushed or pushed to full deployment.Attempts to do so resulted in the dissection of the circumflex artery, clotting in the lad and fragments of the coil, which unraveled upon retrieval attempts with a snare.The coil was partially removed through the microcatheter; some of the coil had to be left inside the patient extending from the lad into the aorta.The patient was untreated for both aneurysms, required stenting of the circumflex artery and will require anticoagulants for 6 months before being considered for further treatment.However, the patient was stable.
 
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Brand Name
INTERLOCK
Type of Device
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14606655
MDR Text Key293436463
Report Number2134265-2022-06455
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729765035
UDI-Public08714729765035
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K132578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number0028978473
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2022
Initial Date FDA Received06/06/2022
Supplement Dates Manufacturer Received06/21/2022
11/23/2022
Supplement Dates FDA Received07/15/2022
12/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2022
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 Outcome(s) Required Intervention;
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