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

Model Number	35615
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device broke and was left inside the patient the target lesion was located in the right common femoral artery (cfa).A.038 accustick ii was selected for use after the physician experienced difficulty in getting intra aterial access.The sheath was successfully placed in the right cfa.During procedure, after a guidewire was placed over the aortic bifurcation and into the left external iliac artery, the physician observed a foreign body present in the left common iliac artery.After examination of the device, it was determined that the foreign body was the radiopaque (ro) marker of the accustick sheath.Snaring was attempted to remove the ro marker but was unsuccessful.Consequently, the physician placed a stent to trap the ro marker preventing embolization.No further patient complications reported and the patient's condition was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.No visual damages were observed with the cannula, dilator, introducer needle and stylet.Residues found in the device indicate use and handling of the device.The radiopaque (ro) marker was detached from the sheath and it was not returned for analysis.Marker impression on the sheath surface indicates the ro marker had been properly assembled and swaged onto the distal end, drag marks toward distal end were observed in the sheath indicating the ro marker was pulled out from the sheath.
Event or Problem Description
It was reported that the device broke and was left inside the patient the target lesion was located in the right common femoral artery (cfa).A.038 accustick ii was selected for use after the physician experienced difficulty in getting intra aterial access.The sheath was successfully placed in the right cfa.During procedure, after a guidewire was placed over the aortic bifurcation and into the left external iliac artery, the physician observed a foreign body present in the left common iliac artery.After examination of the device, it was determined that the foreign body was the radiopaque (ro) marker of the accustick sheath.Snaring was attempted to remove the ro marker but was unsuccessful.Consequently, the physician placed a stent to trap the ro marker preventing embolization.No further patient complications reported and the patient's condition was stable.

• Brand Name: ACCUSTICK II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8748773
• Report Number: 2134265-2019-07620
• Device Sequence Number: 1690418
• Product Code: KGZ
• UDI-Device Identifier: 08714729157588
• UDI-Public: 08714729157588
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 03/15/2022
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0023497010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention