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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 Difficult to Remove (1528); Material Separation (1562); Material Deformation (2976)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/01/2022
Event Type  Injury  
Manufacturer Narrative
Patient identifier: requested, not provided.Age & date of birth: requested, not provided.Patient sex: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Udi - n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k): k062858, k082644.The actual sample upon receipt was only a sheath.Visual inspection found that it had been fractured at approximately 87mm from the distal end and had been divided into a fractured piece and the main body.The length of main body was approximately 13mm, and it was likely that there was no missing part.Magnifying inspection of the fractured section obtained following results.An elongated section and forceps marks were found at the part of involved section.It had been scratched in the vicinity of fractured section.Magnifying inspection of the other sections obtained following results.It had been crushed at approximately 62mm and 78mm from the distal end of fractured piece, and at the sheath supporter in the main body.No anomaly such as a scratch was found in other sections.Electron microscopic inspection of the fractured section obtained following results: [fractured piece] the fracture surface had a smooth shape.The stretched and torn shapes were found at the part of involved section.A dent shape was found at the part of involved section.[main body] the fracture surface had a smooth shape.The stretched and torn shapes were found at the part of involved section.From investigation of the actual sample and the reported issue, assuming that force was applied in the removal direction after the suture needle came into contact with the sheath, the following simulation test was performed.After a scratch was made on the sheath using a suture needle, force was applied in the removal direction while being fixed with a thread.As a result, the sheath was fractured.Electron microscopic inspection of the fractured section of simulated product obtained following results.The fracture surface had a smooth shape.The stretched and torn shapes were found at the part of involved section.A dent shape was found at the part of involved section.From the above, it was inferred that the condition of simulated product was similar to the condition of actual sample.The shape of fractured section varies depending on the angle at which the sharp object hits and the difference in force.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.Based on the investigation result and the reported issue, it was likely that a sharp object such as a suture needle came into contact with the sheath, resulting in the scratch.Then, force was applied in the removal direction, and it was fractured starting from the scratch.In addition, the forceps marks and crushes found in the actual sample were likely to have occurred during the procedure or when it was removed from the inside of the patient's body.However, since the details of the procedure were unknown, the cause of the occurrence could not be clarified.Relevant ifu reference: "do not scratch the sheath with needle point, cutting tool, or other edged tools." terumo medical products (tmp) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
 
Event Description
The user facility reported that the involved product was used to secure the drip route during an ablation procedure.After all procedures were complete, z suturing was performed around the sheath.When the sheath was attempted to be removed after temporarily fixing it, difficulty was felt.The user attempted to pull it out with a little more force; however, the sheath cut off, and only the hub part came out.The sheath fractured and the tip part remained in the patient's body.We performed the procedure to retrieve it.The arrhythmia department did not remove the remaining sheath tip, the surgical department removed and treated it.The cross section of the cut sheath part was confirmed and found that it was flattened by a fairly strong pressure.When it was a little difficult to pull out after suturing, it was thought that the sheath had been pierced with the needle, not that it had been cut.The procedure outcome was not reported.The final patient impact was not harmed.The event occurred intra-operative.
 
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Brand Name
GLIDESHEATH
Type of Device
INTRODUCER, 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
gina digioia
reg. no. 2243441
950 elkton blvd
elkton, MD 21921
6402040886
MDR Report Key15455304
MDR Text Key300265102
Report Number9681834-2022-00187
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
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 Physician
Type of Report Initial
Report Date 09/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2024
Device Model NumberN/A
Device Catalogue NumberRR-A50K10H
Device Lot Number220124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/01/2022
Initial Date FDA Received09/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
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