MAUDE Adverse Event Report: KANEKA CORPORATION R2P CROSSTELLA RX; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number BD-Q20100ER

Device Problems Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

Since the actual device was not retuned, we investigated the device history records.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.No nonconformity or abnormality was found in the manufacturing processes according to the dhr.We believe the reported problem would not be caused by any defect of the device.Factors that may contribute to the balloon stuck include, but are not limited to the following.Balloon wrapping after deflation may be distorted depending on the number of balloon dilations, themeandering lesion state etc.As a result, removal resistance to the sheath (gc) may increase.Also, if the deflation is insufficient, the balloon will be caught on the tip of the sheath or gc, and the balloon will not be able to be retracted into the sheath or the gc.The balloons were stuck due to such causes, and in that state, the balloons were pulled due to strong pulling and were broken.In addition, ifu has the following notes: [precautions during usage] 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.) 21.While inserting this device into the blood vessel or removing this device from the blood vessel, make sure that the balloon is completely deflated.( a device with larger and longer balloon requires a longer deflation time.) 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.

Event Description

A cardiologist was performing a peripheral intervention using the r2p crosstella to balloon in the tibial vessel via femoral access.He had inflated the balloon in the tibial vessel and then deflated it without difficulty.Upon retraction of the balloon the md noticed resistant in the proximal sfa area where the balloon was stuck.As he pulled harder to try and remove the balloon, the balloon broke off from the shaft of the balloon remaining inside the patient while the shaft was removed.Multiple attempts to snare was unsuccessful so the md chose the crush the balloon against the vessel wall with a stent.

• Brand Name: R2P CROSSTELLA RX
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima,kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• Manufacturer Contact: tamiji fujimoto ; 2-3-18; nakanoshima,kita-ku; osaka-city, osaka 530-8-288 ; JA 530-8288
• MDR Report Key: 10064346
• MDR Text Key: 196939571
• Report Number: 3002808904-2020-00008
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: BD-Q20100ER
• Device Lot Number: SP129249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other