MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Date of birth: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- lead tech.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, investigation conclusions code 11 has been referenced.A review of the device history record and the shipping inspection record of the involved product code/lot# combinations were conducted with no findings.Please see mdr (b)(4) for the importer report.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that the doctor used the glidewire through a needle into the pericardium and it appeared that part of it became sheared off.The piece was left in the patient and then appears to be no issues with the patient due to this occurrence.It was not removed.Terumo medical received a user facility medwatch report # (b)(4).The event description states: "pt was on the table having a pericardiocentesis and physician using a terumo guide wire and when the wire was being removed, the distal part of the guidewire was retained in the pericardia! space, physician aware w/ no harm to the patient and image captured on flouro in pt chart." the original intended procedure was a pericardiocentesis.The location where the event occurred was the electrophysiology lab.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section g2.Terumo tmc performed a maude search on 19aug2021.Report number (b)(4) was found and was confirmed to be of the same reported event, and therefore the maude report has been provided.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide an update to the device return date in section d9, update section h3, and to provide the completed investigation results.It was initially reported that the device was available; however, was confirmed not to be available.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Ifu states: do not manipulate or withdraw the glidewire through a metal entry needle or a metal dilator.Manipulation and/or withdrawal through a metal entry needle or a metal dilator may result in destruction and/or separation of the outer polyurethane coating requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.It is known that the outer layer of the guidewire m may peel off when the guidewire m is used in combination with a metal needle; it was presumed that the outer layer might have peeled off due to the combination use of the actual sample and a metal needle.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12202978
• Report Number: 9681834-2021-00132
• Device Sequence Number: 4440454
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: 04987350773197
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: GR3508
• Device Lot Number: 200604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/19/2021; 11/05/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/27/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female