MAUDE Adverse Event Report: KANEKA CORPORATION CROSPERIO RX; CROSPERIO RX PTA BALLOON DILATATION CATHETER

Catalog Number	BD-B20200LR
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results of investigation the device was not returned.The device history records (dhr - batch record) of the concerned device was reviewed and no nonconformity or abnormality in the manufacturing processes was found.Probable cause and comments: although the device was not returned, it was determined to be a serious health hazard because of the remains in the body due to the rupture of the device and the surgical procedure performed to remove the remaining pieces.The surgeon informed us that the event was a serious health hazard.The surgeon commented that he considered the event to be caused by an unintended procedure and not by the device, and therefore, there were no problems with the manufacturing or design.
Event or Problem Description
The patient used the device for treatment of the anterior tibial artery.After the treatment, the patient had difficulty in removing the sheath due to a kink of the guide wire (hereinafter referred to as "gw"), and the sheath was moved forward while pulling the balloon toward the hand.The sheath was moved forward while the balloon was pulled toward the hand side.As the procedure was repeated, the catheter shaft broke at the port of the gw and the balloon remained on the gw.After that, bilateral cfa cut-downs were performed.The remnant was successfully removed.Angiography confirmed complete removal of the remnant and the patient was stabilized.

• Brand Name: CROSPERIO RX
• Common Device Name: CROSPERIO RX PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 53082 88; JA 5308288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settsu, osaka 56600 72; JA 5660072
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 10760-28 ; JA 1076028
• MDR Report Key: 17840867
• Report Number: 3002808904-2023-00005
• Device Sequence Number: 19930041
• Product Code: LIT
• UDI-Device Identifier: 04540778163430
• UDI-Public: 04540778163430
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K152887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: BD-B20200LR
• Device Lot Number: SR033599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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: Other
• Patient Sex: Unknown