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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA GLIDESHEATH INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problems Peeled/Delaminated (1454); Migration (4003)
Patient Problems Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Event Date 06/15/2022
Event Type  Injury  
Manufacturer Narrative
Pma/510(k): k062858, k082644. Since the lot number was unknown, history inspections could not be performed. Since the lot number was unknown, the complaint file of the product of involved product code/lot number combination from other facilities could not be searched. Terumo medical products (tmp) is submitting this report on behalf of (b)(4) factory of terumo corporation (manufacturer) registration no. (b)(4).
 
Event Description
The user facility reported that during a primary percutaneous coronary intervention (stemi) procedure, radial access was not achieved, and ic attempted femoral access. The plastic angled mini guidewire from the glidesheath kit involved was used through an externally sourced metallic percutaneous entry needle. The coating sheared off at the tip and embolized to the patient's lungs. The patient remained in the intense care unit (icu). There was no attempt to remove the embolized coating as decided by clinicians. The patient has a high body mass index (bmi) causing femoral puncture to be problematic. No medical intervention to remove coating done per clinician decision. The event occurred intra-operative.
 
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Brand NameGLIDESHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer Contact
stephanie handy
reg. no. 2243441
950 elkton blvd
elkton, MD 21921
9499890491
MDR Report Key14945841
MDR Text Key295425747
Report Number9681834-2022-00122
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K033681
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberRS*B60N25AQ5
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/19/2022
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: 07/07/2022 Patient Sequence Number: 1
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