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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER
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BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER Back to Search Results
Model Number 35615
Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/17/2022
Event Type  Injury  
Event Description
It was reported that the radiopaque marker on the accustick ii device dislodged and could not be retrieved.A.038 accustick ii was selected for use in a procedure treating the liver.While removing the 6 french accustick dilator from the patient, mild resistance was felt at the liver capsule.A gentle traction was maintained and the device was removed; however, the distal circular radiopaque marker of the outer 6 french sheath was retained within the access tract.A 6 french vascular sheath was then advanced over the wire, and the radiopaque marker re-advanced over the wire.An attempt was made to engage the marker into the sheath using the curved tip of the non-boston scientific (bsc) wire that had caught on the marker, but this was unsuccessful as the marker displaced from the 6 french sheath.The marker became lodged in a distal splenic vein branch.This was accessed with a non-bsc guidewire and catheter, and another attempt was made to remove the marker; however, it did not dislodge.The sheath was then upsized to an 8 french, and further attempts at fluoroscopic-guided retrieval of the marker through the sheath with a non-bsc wire and snare were also unsuccessful.Attention was then returned to retrieval of the retained accustick marker.Another attempt at removing was made; however the accustick marker dislodged into a peripheral right portal vein branch given the newly restored antegrade flow across the stenosis.Attempts were made to access this branch from the current site, but the catheter angle precluded optimal access.The radiopaque marker traveled distally into a peripheral portal branch.Attempts were made using a hydrophilic non-bsc catheter, non-bsc guidewire, and sterling balloon over a non-bsc wire.However, additional attempts were stopped given the now peripheral location of the radiopaque marker.The decision was made to leave the marker in place.
 
Event Description
It was reported that the radiopaque marker on the accustick ii device dislodged and could not be retrieved.A.038 accustick ii was selected for use in a procedure treating the liver.While removing the 6 french accustick dilator from the patient, mild resistance was felt at the liver capsule.A gentle traction was maintained and the device was removed; however, the distal circular radiopaque marker of the outer 6 french sheath was retained within the access tract.A 6 french vascular sheath was then advanced over the wire, and the radiopaque marker re-advanced over the wire.An attempt was made to engage the marker into the sheath using the curved tip of the non-boston scientific (bsc) wire that had caught on the marker, but this was unsuccessful as the marker displaced from the 6 french sheath.The marker became lodged in a distal splenic vein branch.This was accessed with a non-bsc guidewire and catheter, and another attempt was made to remove the marker; however, it did not dislodge.The sheath was then upsized to an 8 french, and further attempts at fluoroscopic-guided retrieval of the marker through the sheath with a non-bsc wire and snare were also unsuccessful.Attention was then returned to retrieval of the retained accustick marker.Another attempt at removing was made; however the accustick marker dislodged into a peripheral right portal vein branch given the newly restored antegrade flow across the stenosis.Attempts were made to access this branch from the current site, but the catheter angle precluded optimal access.The radiopaque marker traveled distally into a peripheral portal branch.Attempts were made using a hydrophilic non-bsc catheter, non-bsc guidewire, and sterling balloon over a non-bsc wire.However, additional attempts were stopped given the now peripheral location of the radiopaque marker.The decision was made to leave the marker in place.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.It was observed that the ro marker was missing and the sheath distal tip was damaged.Microscope inspection revealed that the device was inspected under microscope and it was observed damaged at the distal tip.It's important to mention that evidence of correct ro marker colocation was observed at sheath distal end section, however, the ro marker was missing.For media inspection, a photo was attached to the complaint record and is was possible to observed only the pouch label and no device was visible.
 
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Brand Name
ACCUSTICK II
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14712934
MDR Text Key294258541
Report Number2134265-2022-06515
Device Sequence Number1
Product Code KGZ
UDI-Device Identifier08714729194514
UDI-Public08714729194514
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number35615
Device Catalogue Number35615
Device Lot Number0029120808
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2022
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;
Patient Age10 MO
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