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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.
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Type of DeviceSHIRANUI EX
Manufacturer (Section D)
osaka, 530-8 288,
JA 530-8288,
Manufacturer Contact
tokyo, 107-6-028
MDR Report Key10394856
MDR Text Key202812929
Report Number3002808904-2020-00015
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
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 Received08/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSE75-7040
Device Lot NumberSR040310
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/12/2020 Patient Sequence Number: 1