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

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.

• 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 Key: 15455304
• MDR Text Key: 300265102
• Report Number: 9681834-2022-00187
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033681
• Number of Events Reported: 1
• 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 Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: RR-A50K10H
• Device Lot Number: 220124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other