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Catalog Number CH45-5040
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 12/04/2019
Event Type  Injury  
Manufacturer Narrative
The catheter without distal part of the balloon was returned. The balloon portion was broken at about 1cm from the tip. 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 was damaged by the hardened sharp edge of the anastomosis 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.
Event Description
Ohicho3 is an otw-type pta balloon catheter compatible with 0. 035 inch guidewire. Ohicho3 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". The balloon rupture occurred when the balloon was repeatedly inflated at approximately 22 atm. When it was pulled out, the tip of the catheter was broken. The tip of the catheter with distal part of the balloon broke may have remained inside the body because it was not found.
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Brand NameOHICHO3
Manufacturer Contact
tamiji fujimoto
osaka, nakanoshima,kita-ku 530-8-288
JA   530-8288
MDR Report Key9519173
MDR Text Key189049412
Report Number3002808904-2019-00033
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Catalogue NumberCH45-5040
Device Lot NumberSP079178
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 Received12/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2019
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: 12/26/2019 Patient Sequence Number: 1