MAUDE Adverse Event Report: KANEKA CORPORATION METACROSS OTW; PTA BALLOON DILATATION CATHETER

Catalog Number	BD-L80080CW
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returned.The device history records (dhr) of the device concerned were reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections for every product, and the finished product inspections on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.We assume the cause of this as follows: the event may have been influenced by procedural factors, such as excessive traction associated with the device becoming stuck within the sheath, as well as patient-related factors, such as vessel fragility.In the instructions for use of metacross otw (3210-2), we state the potential of known risk as below.[precautions during usage]: 11.Do not insert or remove the catheter rapidly.(operating rapidly may damage the catheter or injure the vascular intima.).16.If any abnormality such as strong resistance is experienced while manipulating the catheter, the procedure should be discontinued immediately.The cause should be verified and appropriate measures should be taken.(continuing the operation with excessive force may result in damage to the catheter or in vascular wall injury.).22.If resistance is felt during post procedural withdrawal of this device, it is recommended to withdraw the entire system together with the introducer / guide sheath.[complications].Device failures: difficulty in removing the device, adverse events: local internal bleeding or hematoma, intimal rupture, vascular dissection, vascular perforation, vascular rupture.
Event or Problem Description
During removal of the device, resistance was encountered within the 6fr sheath.As the removal was continued, the iliac artery was injured, resulting in bleeding (estimated to be >250 ml).Appropriate medical intervention was performed, and the patient's condition ultimately stabilized.

• Brand Name: METACROSS OTW
• 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: 24466011
• Report Number: 3002808904-2026-00003
• Device Sequence Number: 13165667
• Product Code: LIT
• UDI-Device Identifier: 04540778156999
• UDI-Public: 04540778156999
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152080
• 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): 02/09/2026

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-L80080CW
• Device Lot Number: SR034563
• 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: 02/09/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• 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