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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 Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the coil made a hole in the catheter.Vascular access was obtained via ipsilateral approach in a moderately calcified internal iliac artery.During the procedure, two to three coils were placed even though the angle was steep.A 15mmx40cm interlock-35 was selected and the coil became not smooth upon advancing when it reached the curve part of the proximal side of the interlocking arm.Coil movement inside the catheter became suspicious.When the remaining coil (about 2cm) was tried to insert, the locking arm got separated.The coil was pulled back by recoiling and it penetrated the 5fr non-bsc angiographic catheter and created a hole.After that, it was tried to push using a non-bsc device, but the locking arm section came in contact with the hole of the damaged catheter.Thus, the coil became unable to advance further and was then removed together with the catheter.The coil was able to be removed outside the body.The procedure was completed with another of the same device.No complications reported and the patient is stable with no adverse health hazard.
 
Event Description
It was reported that the coil made a hole in the catheter.Vascular access was obtained via ipsilateral approach in a moderately calcified internal iliac artery.During the procedure, two to three coils were placed even though the angle was steep.A 15mmx40cm interlock-35 was selected and the coil became not smooth upon advancing when it reached the curve part of the proximal side of the interlocking arm.Coil movement inside the catheter became suspicious.When the remaining coil (about 2cm) was tried to insert, the locking arm got separated.The coil was pulled back by recoiling and it penetrated the 5fr non-bsc angiographic catheter and created a hole.After that, it was tried to push using a non-bsc device, but the locking arm section came in contact with the hole of the damaged catheter.Thus, the coil became unable to advance further and was then removed together with the catheter.The coil was able to be removed outside the body.The procedure was completed with another of the same device.No complications reported and the patient is stable with no adverse health hazard.
 
Manufacturer Narrative
E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The picture and video provide appears, that the coil (interlocking arm) perforate the catheter and detached from the delivery wire during the insertion process.A main coil and non-bsc catheter were returned for this complaint.The coil was returned stretched and kinked.The coil (interlocking arm) perforate the exterior sheath of the non-bsc catheter.No more damages were found in the returned device.Microscopic inspection of the main coil revealed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies were noted.The coil was returned stretched and kinked.Dimensional inspection of the main coil was performed and revealed that the no.Of distal fiber bundles, outer diameter (od) of the zap tip and primary coil were within specification.However, the no.Of proximal fiber bundles were lacking.
 
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Brand Name
INTERLOCK-35
Type of Device
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9865556
MDR Text Key184472147
Report Number2134265-2020-03656
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729793144
UDI-Public08714729793144
Combination Product (y/n)N
PMA/PMN Number
K133208
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/26/2022
Device Model Number83786
Device Catalogue Number83786
Device Lot Number0024024993
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2020
Date Manufacturer Received05/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MERIT MEDICAL 5 FRV (0.035) GUIDE CATHETER; MERIT MEDICAL 5 FRV (0.035) GUIDE CATHETER; RADIFOCUS GUIDEWIRE; RADIFOCUS GUIDEWIRE; MERIT MEDICAL 5 FRV (0.035) GUIDE CATHETER; RADIFOCUS GUIDEWIRE
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