MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS; DEVICE, HEMOSTASIS, VASCULAR

Model Number N/A

Device Problems Sticking (1597); Failure to Advance (2524); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

Udi - unknown due to the lot number being unknown.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.The production lot number was not provided by the user facility, which prevented a meaningful review of production and complaint records.See mdr 3013394970-2017-00362 & mdr 3013394970-2017-00363 for the other two patients and two other devices reported.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported the dilator was inserted into the angioseal sheath, arrow to arrow.Dr advanced sheath over the guidewire, but the sheath got stuck and didn't want to advance into artery.The doctor pushed harder, but he didn't want to force the sheath as it might damage the artery.They did a groin shot before opening the angioseal - femoral access was as indicated, no stenosis, bigger than 4mm, above bifurcation.This incident happened with three different angioseals on three different patients.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide codes for the patient & device codes that were unable to be selected in initial report & to provide the evaluation results.No evaluation could be conducted due to the device not being returned.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.There is no evidence that this event was related to a device defect or malfunction.With no device return the exact cause of the reported event cannot be definitively determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 2101 cottontail ln.; somerset NJ 08873
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 2101 cottontail ln.; somerset NJ 08873
• Manufacturer Contact: terry callahan ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6865620
• MDR Text Key: 86591054
• Report Number: 3013394970-2017-00361
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P930038
• 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,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 610132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• 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