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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA GLIDESHEATH SLENDER INTRODUCER, CATHETER

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TERUMO CORPORATION, ASHITAKA GLIDESHEATH SLENDER INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Pseudoaneurysm (2605)
Event Date 12/12/2017
Event Type  Injury  
Manufacturer Narrative
Patient identifier - requested, not provided. Age and date of birth - requested, not provided. Sex - requested, not provided. Weight - requested, not provided. Ethnicity - requested, not provided. Race - requested, not provided. Expiration date - unknown due to unknown lot number. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date - unknown due to unknown lot number. The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted. A review of the device history record and the shipping inspection record of the product code/lot# combination was unable to be conducted due to the unknown lot number. The same user facility reported similar events. This report is for the first device, see mdrs: 9681834-2017-00273 and 9681834-2017-00274 for the second and third devices. With no device return the exact cause of the reported event cannot be definitively determined based on the available information. Ifu for this product has the instructions as follows: advance or withdraw the mini guide wire slowly. If resistance is met, do not advance or withdraw the mini guide wire until the cause of resistance is determined. (b)(4).
 
Event Description
The user facility reported they used to use 20-1060 and switched to the slender. They believe the. 021" wire in the slender kit is stiffer. They have experienced a few pseudo aneurysms in the past months and attribute it to the stiffer wire or the vasc band. All of the patients recovered and no surgery was needed. The procedure was successful.
 
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Brand NameGLIDESHEATH SLENDER
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer Contact
terry callahan
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key7178442
MDR Text Key96847188
Report Number9681834-2017-00272
Device Sequence Number1
Product Code DYB
UDI-Device Identifier04987350718068
UDI-Public04987350718068
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142183
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberRM*RS6F10PA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/13/2017
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: 01/10/2018 Patient Sequence Number: 1
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