MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 8FR ANGIO-SEAL STS PLUS US; DEVICE, HEMOSTASIS, VASCULAR

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Explanted date - device was not explanted.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that an expired angio-seal was implanted in a patient.Additional information was received on (b)(6) 2021: procedure performed was a left heart catheterization (lhc) percutaneous coronary intervention (pci) with impella support.The circulator nurse stepped out of the room, and the other nurse went and pulled an angio-seal device out of the par excellence supply cabinet.The device was handed to the scrub tech and the nurse went back to mixing the medication drip.After it was implanted in the patient's artery is when it was being entered in the document system was when it was noted that the angio-seal device was expired.The procedure sheath size used was a 7fr.A pre-deployment angiogram was performed.Hemostasis achieved successfully.The patient has not showed any complications since the implant.The patient was in stable condonation.There have been no infections reported.The estimated blood loss was less than 250cc's.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.H6: investigation findings 114 is based upon the evaluation of user facility information.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint could be confirmed for user error since the user deployed an expired product.Per customer narrative there were no issues with the device and it was correctly deployed/used by facility beyond its expiration date.There are adequate labeling indications available on packaging to identify the expiration date along with instructions available in instructions for use to ensure that this type of failure mode could be avoided.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing, design or quality system issues may have led to this event.

• Brand Name: 8FR ANGIO-SEAL STS PLUS US
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset NJ 08873
• MDR Report Key: 11814395
• Report Number: 3013394970-2021-00272
• Device Sequence Number: 11550603
• Product Code: MGB
• UDI-Device Identifier: 00389701011851
• UDI-Public: 00389701011851
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 610121
• Device Lot Number: 06100129
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 112