MAUDE Adverse Event Report: KANEKA CORPORATION SHIRANUI EX

Catalog Number SE45-6040

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2021

Event Type  Injury  

Manufacturer Narrative

The actual device was returned.It was confirmed that the balloon was 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: the balloon may have damaged by the stent of shunt pta and should have been ruptured when the balloon was inflated.While removing it from the patient, the bulky portion of the ruptured balloon was caught on the sheath and could not be pulled back any more.Further attempts to forcibly pull back the device resulted in breakage of the balloon and the tip, and the broken pieces remained in the patient's blood vessel.

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 "crosstella otw" (otw type pta balloon dilatation catheter,0.018" guidewire compatible) in us under 510(k)# k160004.".

• 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 (Section G): KANEKA CORPORATION OSAKA PLANT; torikai-nishi 5-1-1; settsu; osaka, 56600 72; JA 5660072
• Manufacturer Contact: joji ; akasaka; minato-ku; tokyo, 107-6-028
• MDR Report Key: 13217349
• MDR Text Key: 288274226
• Report Number: 3002808904-2022-00002
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SE45-6040
• Device Lot Number: SR101245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2021
• 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