MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SUPER SHEATH INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	28186
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal end of the sheath was detached.The target lesion was located at superfacial femoral artery.A 5fr x 11cm super sheath was selected for use.During the procedure, the physician inserted a non bsc closure device.After which, a non bsc wire was inserted and the sheath was removed over the wire.However, it was noted that the distal end of the sheath had separated.The leg was checked and imaged and it was noted that the distal sheath tip mark on the sheath had broken off in the sfa and travelled down to the popliteal artery.The physician then used a mach 1 guide catheter to aspirate the distal tip of the sheath out in the body and it was then lodged in the soft tissue track.Finally, the physician retrieved the distal end of the sheath out of the soft tissue track of the patient.The procedure was completed with no wire left in the sheath.No further patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Only the sheath and another manufacturer's device that was inserted in the sheath was returned.The returned product was investigated and observed that the sheath tube was torn off at the 5 mm point from the sheath tip.The rest (separated tip part) was not returned.The returned product was observed and magnified for the torn-off portion.It was observed there was a cut on the sheath tube that might had been made by sharp instrument.It looked like the rest of the broken part was and detached/torn-off when the sheath was pulled out in the procedure.
Event or Problem Description
It was reported that the distal end of the sheath was detached.The target lesion was located at superfacial femoral artery.A 5fr x 11cm super sheath was selected for use.During the procedure, the physician inserted a non bsc closure device.After which, a non bsc wire was inserted and the sheath was removed over the wire.However, it was noted that the distal end of the sheath had separated.The leg was checked and imaged and it was noted that the distal sheath tip mark on the sheath had broken off in the sfa and travelled down to the popliteal artery.The physician then used a mach 1 guide catheter to aspirate the distal tip of the sheath out in the body and it was then lodged in the soft tissue track.Finally, the physician retrieved the distal end of the sheath out of the soft tissue track of the patient.The procedure was completed with no wire left in the sheath.No further patient complications were reported and the patient's status was fine.

• Brand Name: SUPER SHEATH INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8208813
• Report Number: 2134265-2018-64694
• Device Sequence Number: 18882599
• Product Code: DYB
• UDI-Device Identifier: 14543527181799
• UDI-Public: 14543527181799
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K060190
• 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): 02/15/2019

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: 05/31/2021
• Device Model Number: 28186
• Device Catalogue Number: 28186
• Device Lot Number: 18F27B4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/15/2019
• 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
• Patient Age: 40 YR