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Catalog Number SE75-6040
Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 07/17/2020
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 anastomotic site 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 anastomotic site 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 "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. " the balloon of this product ruptured during treatment at the anastomotic site. When the doctor pulled it out, the balloon has broken. Later, the doctor discovered that the balloon was left behind in the patient body. A surgical procedure was performed to remove the balloon, and the broken balloon was removed.
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Type of DeviceSHIRANUI EX
Manufacturer (Section D)
osaka, 530-8 288,
JA 530-8288,
Manufacturer (Section G)
5-1-1 torikai-nishi
osaka, 566-0 072
JA 566-0072
Manufacturer Contact
tokyo, 107-6-028
MDR Report Key10604980
MDR Text Key209163441
Report Number3002808904-2020-00018
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 09/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2020
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 Received09/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial