MAUDE Adverse Event Report: KANEKA CORPORATION R2P CROSSTELLA RX; PTA BALLOON DILATATION CATHETER

Catalog Number	BD-Q50100ER
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results of device examination: the device was found to be fractured at approximately 1,070 mm from the distal tip of the shaft.In addition, marked elongation was observed from the guidewire port toward the proximal side, and the effective length of the catheter was confirmed to be increased by approximately 340 mm.No leakage or rupture of the balloon was observed.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: all fractured components of the device were successfully retrieved; however, retrieval required additional vascular access at a site different from the initial access (left femoral artery instead of the radial artery), resulting in an invasive intervention.Therefore, this event was classified as a serious injury.Based on the investigation, this event is considered to be procedure-related, involving multiple contributing factors, including the continuation of withdrawal while the device shaft was caught on a previously implanted stent, which likely resulted in excessive tensile force being applied to the device.In the instructions for use of r2p crosstella rx (3254-0), 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: breakage of the balloon and / or the catheter shaft difficulty in removing the device.
Event or Problem Description
The device was used for pre-dilatation of a superficial femoral artery (sfa) lesion.After dilatation of the target lesion, resistance was encountered during withdrawal of the device.While continuing the withdrawal carefully, the device was observed to have caught on a previously implanted stent located in the common iliac artery, and a shaft fracture of the device was confirmed.Subsequently, the left femoral artery was punctured and a snare was used to retrieve the fractured portion of the device.After retrieval, no intravascular retained fragments were observed.The target lesion was then treated using a drug-coated balloon, and the procedure was completed.No patient injury has been reported.

• Brand Name: R2P CROSSTELLA RX
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima kita-ku; osaka, osaka 530-8 288; JA 530-8288
• 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: 24824606
• Report Number: 3002808904-2026-00005
• Device Sequence Number: 9221850
• Product Code: LIT
• UDI-Device Identifier: 04540778175396
• UDI-Public: 04540778175396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152873
• 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): 03/24/2026

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-Q50100ER
• Device Lot Number: SR124195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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