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Catalog Number SE75-6040
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/01/2020
Event Type  Injury  
Manufacturer Narrative
The actual device was returned as a single catheter. It was confirmed that the balloon part about 4 cm from the tip of the product was constricted. 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 article was inserted, the tip of the balloon was fixed at the lesion or the like, and the article was twisted in that state, so that the central portion of the balloon was twisted. The balloon was inflated, but the balloon at the tip portion could not be deflated from the twisted portion.
Event Description
Shiranui ex is a rapid-exchange 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 with a calcified lesion, the balloon was unable to deflate. The product was operated several times with an inflation device, but deflation could not be performed, so the balloon of the product was directly punctured with a puncture needle, and the product was removed.
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Type of DeviceSHIRANUI EX
Manufacturer (Section D)
530-8 288
JA 530-8288
Manufacturer Contact
tamiji fujimoto
osaka, 530-8-288
JA   530-8288
MDR Report Key10095226
MDR Text Key195381955
Report Number3002808904-2020-00010
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 05/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Catalogue NumberSE75-6040
Device Lot NumberSP079173
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 Received05/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2019
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: 05/28/2020 Patient Sequence Number: 1