MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 6FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot# combination was conducted with no findings.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
The user facility reported that a female patient ended up with a retro-peritoneal bleed with a 6f angio-seal device.The bleed developed later after the procedure.The physician claims that access site was not above inguinal ligament, and at the common femoral artery (cfa).It is unknown what the patient's heparin dose was.The physician used ultra-sound to gain access and claims that access was normal.The blood loss was less than 250cc.The patient condition was reported to be doing better.The procedure outcome was otherwise good.Additional information was received on 15jan2020.The procedure was a mesenteric intervention.It was a balloon or stent procedure using a 6fr.Procedural sheath.A pre deployment angiogram was performed.Hemostasis was achieved at the time of deployment of the angio-seal device.The patient was in stable condition.Additional information was received on 17jan2020.Manual pressure was maintained to stop the bleed.

• Brand Name: 6FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset, nj
• MDR Report Key: 9695528
• Report Number: 3013394970-2020-00017
• Device Sequence Number: 19539179
• Product Code: MGB
• UDI-Device Identifier: 00389701011868
• UDI-Public: 00389701011868
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 610119
• Device Lot Number: 06099539
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Weight: 45