MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS; DEVICE, HEMOSTASIS, VASCULAR

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.A review of the device history record of the product code and lot number combination was conducted with no findings.The actual device was not available for returned; therefore, an evaluation of the actual device will not be conducted.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.

Event Description

The user facility reported the involved angio-seal insertion sheath was broken.During preparation of the assembly, a tear was found in the tip of the insertion sheath and was determined unable to be inserted into the artery.The device was not used, and another angio-seal device was used to continue the procedure.Subsequently, hemostasis was successfully achieved by the second device.The procedure before deploying the device was coiling (ic-an).A pre-deployment angiogram was performed.The size of the sheath ancillary used was 8 fr.The puncture site was proximal to the inguinal ligament of the right common femoral artery.The vessel diameter was 2.5 mm.No health damages.The event occurred pre-treatment.The patient was not injured, medical or surgical intervention was not required.There were no other devices or equipment used with the reported product.

Manufacturer Narrative

This report is being sent as follow-up # 1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint was unable to be confirmed as the sample was not available for evaluation.An exact root cause for the issue was unable to be determined.The device history record (dhr) review determined that 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.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea)/ hazard based risk table (hbrt).

• Brand Name: 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset NJ 00873
• Manufacturer (Section G): TERUMO PUERTO RICO LLC; innovacion street lot 21; caguas west industrial park; caguas, 00725
• Manufacturer Contact: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 17196284
• MDR Text Key: 317929790
• Report Number: 3013394970-2023-00258
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 610133
• Device Lot Number: 0000268079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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