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

Catalog Number RS*A60K10AQ

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

Expiration date - unknown due to unknown lot number.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k062858, k082644.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.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and the shipping inspection record.Ifu states: do not scratch the sheath with needle point, cutting tool, or other edged tools.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that while the professor was retrieving the actual radifocus introducer ii h, after a pta surgery, the sheath's distal tip fractured about 2.5 cm, and it remained in the pulmonary artery.The doctor tried to extract the fractured segment from the patient; however, failed.

• 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8869558
• MDR Text Key: 153551796
• Report Number: 9681834-2019-00143
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RS*A60K10AQ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention