MAUDE Adverse Event Report: KANEKA CORPORATION Crosperio RX; PTA Balloon Dilatation Catheter

Catalog Number	BD-B40040LR
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2026
Type of Reportable Event	Serious Injury

• Brand Name: Crosperio RX
• Common Device Name: 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: akihiro tahara ; 1-12-32; akasaka; minato-ku, tokyo 10760-28 ; JA 1076028
• MDR Report Key: 50927625
• Report Number: 3002808904-2026-00011
• Device Sequence Number: 13446611
• Product Code: LIT
• UDI-Device Identifier: 04540778163072
• UDI-Public: 04540778163072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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 Catalogue Number: BD-B40040LR
• Device Lot Number: SR065526
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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