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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEURMO/KANEKA CORPORATION OSAKA PLANT TAKERU CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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TEURMO/KANEKA CORPORATION OSAKA PLANT TAKERU CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number DC-PY1515UA1
Device Problems Fracture (1260); Material Rupture (1546)
Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)
Event Date 02/18/2020
Event Type  Injury  
Event Description
During a coronary intervention, an over-the wire takeru coronary artery ptca balloon ruptured inside the right coronary artery and then, upon removing the balloon the balloon fractured. When the bulk of the balloon catheter was removed using the standard technique, a portion of the balloon and a portion of the internal lumen of the catheter remained inside the patient at the position of the last inflation. After several techniques, the balloon was removed using another wire and balloon. This caused a prolonged procedure in order to prevent death and morbidity. Reported to manufacturer: terumo file number: (b)(4). The patient presented to our lab with st-elevation myocardial infarction. During this intervention is when the event occurred. Fda safety report id #: (b)(4).
 
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Brand NameTAKERU
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
TEURMO/KANEKA CORPORATION OSAKA PLANT
MDR Report Key9971793
MDR Text Key188389014
Report NumberMW5094173
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDC-PY1515UA1
Device Catalogue NumberDC-PY1515UA1
Device Lot NumberSP038485
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/16/2020 Patient Sequence Number: 1
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