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

Model Number	BD-P50040ER
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please find below the results of our investigation.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.We will submit a follow-up report as soon as the actual device testing is completed.
Event or Problem Description
Left radial access, 6fr 10cm slender, used gwa track 018, pre-dilated focal proximal sfa lesion (90%) with crosstella 2x40x200, then used angiosculpt 5x20x137,then exchanged for gwa 35 260cm, successfully delivered a misago 6x40x200, attempted to post dilate with abbott vascular armada 5x40x135 (not successful, would advance into 1/3 of the stent but no further), attempted to post dilate with r2p metacross 5x40x200 and noticed that while in the descending aorta, the balloon stopped advancing.Physician stopped and went to look.Catheter was visibly looped and the physician tried to advance and pull back to unloop the catheter.Unsuccessful.He then tried to remove the system (wire, balloon and sheath) but the balloon system started causing patient discomfort and resistance was observed.Everything was left in and the patient was transported by ambulance to the university of iowa for vascular surgery intervention.A radial cutdown was performed below the elbow and the system was removed in sections by using a wire cutter.The balloon system was intact but the catheter had kinked and was not able to straighten to remove.The patient received one unit of blood and a xenosure biologic patch to repair the radial artery.Good radial and ulnar pulses were observed at the end of the procedure.
Additional Manufacturer Narrative
Please find below the results of our investigation: 1) 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 including the visual test, shaft pressurized test and the balloon-wrapping test for every product, and the finished product inspections including the shaft tensile strength test and the repetitive balloon inflation/deflation test on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.2) as a result of the actual product survey, no part that was considered to be broken was confirmed other than the part that was cut by surgical intervention.No abnormality was found in the distal tip part, balloon part and gw port.Shaft kink near the proximal side of the gw port is thought to have occurred during surgical intervention.From the above, it is presumed that the only defect is curvature of the product.2.Probable cause(s) and our comment: no nonconformity or abnormality in the manufacturing processes of the device concerned was found.Factors that may contribute to the stuck include, but are not limited to the following.From the images at the time of stuck, it is presumed that the looped 0.018inch gw and 0.035inch gw overlapped with the proximal shaft of the product(1.25mm) in the radial artery,as a result, the product was stuck in the radial artery.In addition, it is presumed that the use of a short 10 cm sheath caused discomfort to the patient due to contact of various devices in the blood vessel, and the system could not be removed, resulting in surgical intervention.We determine that the event reported was caused by the device handling-issues.

• 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, osaka 53082 88; JA 5308288
• MDR Report Key: 12244571
• Report Number: 3002808904-2021-00007
• Device Sequence Number: 4495557
• Product Code: LIT
• UDI-Device Identifier: 04540778166455
• UDI-Public: 04540778166455
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: 02/28/2023
• Device Model Number: BD-P50040ER
• Device Catalogue Number: BD-P50040ER
• Device Lot Number: SR030460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 64