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

Model Number	BD-P50060ER
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records (dhr) of the device concerned was 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.Results of the investigation on returned concerned device: the distal shaft was kinked at 83mm, 101mm, and 114mm, and deformed at 135mm and 213mm from the distal tip.The outer shaft was torn at 283 to 403mm toward the gw port.The catheter shaft was elongated and torn to separate at 512mm.We assume the cause of this as follows: factors that may contribute to shaft breakage include, but are not limited to, the operator delivered the actual device from the tip of the sheath until the gw port of the product came out.Therefore, when the actual device was tried to remove from the sheath, the gw used in combination for some reason became slack at the sheath tip and formed a loop.In that state, the operator further pulled the actual device, so the gw lumen (gw port) of the product was torn in the distal direction by the gw, and the shaft of the product was broken.In the instructions for use of r2p metacross rx (3227-1) , we state the potential of known risk as below; [precautions during usage] this catheter should be used only by physicians skilled in percutaneous vascular therapy.Use this catheter only when emergency surgery can be performed at any time.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.) 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.
Event or Problem Description
Procedure was a peripheral intervention from right radial.Balloon got wrapped around guidewire and got stuck in the radial artery.The balloon and wire were able to be removed without damaging the artery by performing a 2-3cm minor cut down in forearm, and suture everything closed.

• Brand Name: R2P METACROSS RX
• Common Device Name: R2P METACROSS RX PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, 530-8 288; JA 530-8288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settsu-city, osaka 566-0 072; JA 566-0072
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 107-6-028 ; JA 107-6028
• MDR Report Key: 16326647
• Report Number: 3002808904-2023-00001
• Device Sequence Number: 7828242
• Product Code: LIT
• UDI-Device Identifier: 04540778166578
• UDI-Public: 04540778166578
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K163479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: BD-P50060ER
• Device Catalogue Number: BD-P50060ER
• Device Lot Number: SR031462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White