MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER

Model Number	35615
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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.

• Brand Name: ACCUSTICK II
• Common Device Name: 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 Key: 14712934
• Report Number: 2134265-2022-06515
• Device Sequence Number: 5414139
• Product Code: KGZ
• UDI-Device Identifier: 08714729194514
• UDI-Public: 08714729194514
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2025
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0029120808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 MO
• Patient Sex: Unknown