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

Model Number	28211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was fractured.A 7fr x 11 cm.035 gw super sheath introducer sheath was selected for angioplasty procedure.During the procedure, it was noted that the introducer was fractured.The procedure was completed with a different device and there were no patient complications reported.
Additional Manufacturer Narrative
Date of event: used (b)(6) 2023 as the event date was not reported.
Event or Problem Description
It was reported that the device was fractured.A 7frx11 cm.035 gw super sheath introducer sheath was selected for angioplasty procedure.During the procedure, it was noted that the introducer was fractured.The procedure was completed with a different device and there were no patient complications reported.
Additional Manufacturer Narrative
B3 - date of event: used (b)(6) 2023 as the event date was not reported.Device evaluated by mfr: only the sheath was returned as the actual product and the broken tip was enclosed.When the returned product was inspected, it was confirmed that the sheath tube was broken at a position of about 10 mm from the sheath base.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 something 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.The manufacturing records for the batch number (21l24b6) were reviewed and there was no abnormality or discrepancy found.We confirmed the device met the material standard, assemble process and the specification in the reviews.From the investigation of the manufacturing process and each work, it was confirmed that there had been no process that might have caused the damage on the sheath tube.There is no similar complaint of this nature with this batch number.Including this complaint, we have received 12 similar complaints during the past 205 months.They are being carefully monitored to prevent from making this kind of malfunction to happen again.No other issues were identified during the product analysis.

• Brand Name: SUPER SHEATH INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MEDIKIT COMPANY LIMITED; 13-2 yushima 1-chome; bunkyo-ku tokyo 113 ; JA 113
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16882244
• Report Number: 2124215-2023-21040
• Device Sequence Number: 20647115
• Product Code: DYB
• UDI-Device Identifier: 14543527202456
• UDI-Public: 14543527202456
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 11/30/2024
• Device Model Number: 28211
• Device Catalogue Number: 28211
• Device Lot Number: 21L24B6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2021
• 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
• Patient Sex: Unknown