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

Catalog Number RR-A60K10A

Device Problems Material Separation (1562); Physical Resistance (2578)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/23/2018

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.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.The: 510(k): k062858.The actual device was returned for evaluation.Visual inspection upon receipt found that the urethane outer layer had been sheared off on approximately 65 mm - 225 mm from the distal end of the device.Magnifying inspection of the urethane outer layer sheared segment found that the urethane outer layer had been semi-circumferentially sheared off the wire, where the core wire was exposed.The shear cross-section of the urethane outer layer was in the smooth state.The distal end of the sheared urethane outer layer was in the configuration which implied that the separated portion had been ripped off.From these findings, it is assumable that the actual device came into contact with a sharp metallic device and its urethane outer layer was sheared off with it.There is a possibility that the semi- circumferentially sheared urethane layer approximately 160 mm in length may have remained in the patient's body.The outside diameter was measured on the undamaged segment and confirmed to meet the specifications.Reproductive test was performed.The actual sample was used in combination with a metal needle.A current guide wire product sample was inserted into a metal needle and withdrawn from it in the manner of the guide wire sample having contact with the metal needle.The urethane outer layer was semi-circumferentially sheared off from the guide wire sample.The surface of the shear cross-section of the urethane outer layer was confirmed to be in the smooth state.The state of the damage similar to that on the actual sample was duplicated.A review of the device history record and the product release decision control sheet from the involved product code/lot number combination was conducted with relevant findings.There is no evidence that this event was related to a device defect or malfunction.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the actual device was subjected to withdrawal manipulation in the state where its urethane outer layer had contact with the metallic needle used in combination with the actual device.As the result, the urethane outer layer was sheared off the wire.The labeling does address the potential for such an event in the instruction-for-use (ifu) with statements such as the following: do not use a metal cannula as an entry needle.Withdrawing the mini guide wire through a metal cannula or advancing a metal cannula over the mini guide wire may result in shearing of the mini guide wire or scraping of its plastic coating.This may lead to damage to the blood vessel or the sheath, as well as release of fragment from the wire into the blood system.(b)(4).

Event Description

The user facility reported separation of urethane layer on the mini guidewire.During a pacemaker treatment, a metal needle was used for puncture.The actual sample was inserted through the metal needle, and the actual sample was withdrawn with the metal needle.The customer felt resistance and the urethane outer layer was sheared off.A metal needle packed in a sheath kit for pacemaker (st.Jude medical) was used with the reported product.The sheared segment remained in the body and it was impossible to retrieve it.It was reported there was minor harm to the patient.

• Brand Name: GLIDESHEATH
• Type of Device: INTRODUCER 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 Key: 7269779
• MDR Text Key: 100025649
• Report Number: 9681834-2018-00015
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: RR-A60K10A
• Device Lot Number: 171123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2017
• 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): Other