MAUDE Adverse Event Report: KANEKA CORPORATION SHIRANUI EX

Catalog Number SE75-7040

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

The concerned device was returned.It was confirmed that the balloon was twisted and broken.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 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.Probable cause(s) and our comment: when the balloon catheter was inserted, the tip of the balloon was stuck at the lesion or the like, and the balloon catheter was twisted in that state, so that the central portion and distal of the balloon was twisted.After that, the balloon was inflated, but the balloon could not be deflated from the twisted portion of distal.

Event Description

Shiranui ex is an over the wire type semi-compliant pta balloon catheter compatible with 0.018 inch guidewire.Shiranui ex has no approval in usa.However, we intend to report this case as the event occurred on the similar device for "metacross otw" (otw type pta balloon dilatation catheter, 0.035" guidewire compatible) in us under 510(k)# k152080." crosstella otw" (otw type pta balloon dilatation catheter,0.018" guidewire compatible) in us under 510(k)# k160004."." crosstella rx" (rx type pta balloon dilatation catheter,0.018" guidewire compatible) in us under 510(k)#k152873."" crosperio otw" (otw type pta balloon dilatation catheter,0.014" guidewire compatible) in us under 510(k)# k160013." after expanding at the anastomosis, the balloon could not be deflated.The product could not be deflated, so the balloon of the product was directly punctured with a puncture needle from above the skin, and the product was removed.

• Brand Name: SHIRANUI EX
• Type of Device: SHIRANUI EX
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; osaka, 530-8 288,; JA 530-8288,
• Manufacturer Contact: joji ; akasaka; minato-ku; tokyo, 107-6-028
• MDR Report Key: 10394856
• MDR Text Key: 202812929
• Report Number: 3002808904-2020-00015
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: SE75-7040
• Device Lot Number: SR040310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• 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): Required Intervention