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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION SHIDEN HP CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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KANEKA CORPORATION SHIDEN HP CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number SD3-60150
Device Problems Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem Rupture (2208)
Event Date 04/09/2019
Event Type  Injury  
Manufacturer Narrative
The concerned device subject to this reported event, "shiden hp", an rx-type pta balloon catheter compatible with 0. 014"guidewire, is not distributed in us, however, we intend to report this case as the event occurred on one of the similar devices for "crosperio rx" , an rx-type pta balloon catheter compatible with 0. 014" guidewire, which is distributed in us under 510(k)#k152887. Since the used was not returned to the manufacturer, we were not able to analyze it. In addition, we were not able to check dhr because the batch number was unidentified. About the balloon rupture cause of this matter, a balloon extended thing guessed it as possibility by pressure across maximum expansion pressure (rbp) from maneuver information, but was not able to identify blood vessel estrangement and concrete causation with the leak of the stent graft.
 
Event Description
This "shiden hp" pta balloon catheter (hereafter said "balloon catheter") was employed for a post-dilatation of the stent graft. The balloon of the pta balloon catheter ruptured at an inflating pressure of 30 atm -30sec (the rated burst pressure (rbp) of this balloon catheter;20atm). Blood vessel became estranged, and leak occurred from a stent graft. Then, the physician detained a stent graft as an emergency measure more and restored it.
 
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Brand NameSHIDEN HP
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18
nakanoshima,kita-ku
osaka, osaka 53082 88
JA 5308288
Manufacturer Contact
yoshiyuki kitamura
2-3-18
nakanoshima, kita-ku
osaka, osaka 53082-88
JA   5308288
MDR Report Key8665439
MDR Text Key146895595
Report Number3002808904-2019-00013
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 05/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSD3-60150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/04/2019 Patient Sequence Number: 1
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