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

Model Number	28184
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the radioplaque tip broke off.The 80% stenosed target lesion was located in a fistula venous anastomosis of the left arm.A super introducer sheath was selected for use.During the procedure, it was noted that the radioplaque tip broke off when pulling the sheath.The device was removed from the patient was not intact.There were no patient complications reported.
Additional Manufacturer Narrative
H6 patient codes corrected.Only the sheath was returned as the actual product.The broken tip was enclosed.The returned product was investigated and it was confirmed that the sheath tube was torn off at the 17 mm point from the tip of the sheath.Magnifying observation was conducted on the torn-off portion.It was observed there was a breaking section on the sheath tube that might had been made by sharp instrument.Also, it looked like the rest of the broken part was detached /torn-off when the sheath was pulled off in the procedure.
Event or Problem Description
It was reported that the radioplaque tip broke off.The 80% stenosed target lesion was located in a fistula venous anastomosis of the left arm.A super introducer sheath was selected for use.During the procedure, it was noted that the radioplaque tip broke off when pulling the sheath.The device was removed from the patient was not intact.There were no patient complications reported.

• 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: 12434277
• Report Number: 2134265-2021-11256
• Device Sequence Number: 3585598
• Product Code: DYB
• UDI-Device Identifier: 14543527181751
• UDI-Public: 14543527181751
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 28184
• Device Catalogue Number: 28184
• Device Lot Number: 21D12B3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR