VSI MICRO PUNCTURE KIT 4F STIFFEN 7195V PN10138

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for VSI MICRO PUNCTURE KIT 4F STIFFEN 7195V PN10138 manufactured by Vascular Solutions, Inc..

Event Text Entries

[126525568] Pt to have heart cath. Access to right femoral artery, 4f micropuncture introducer inserted on wire. Scalpel was used to widen insertion site, proximal half micropuncture sheath removed from wire noting distal portion of sheath remained in the femoral artery. Unable to retrieve distal portion of sheath. Vascular surgery consulted and took pt to the operating room to retrieve sheath. Pt remained stable throughout the incident. Pt admitted to hospital. Disclosure to pt made.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	8045693
MDR Report Key	8045693
Date Received	2018-11-06
Date of Report	2018-10-30
Date of Event	2018-10-29
Date Facility Aware	2018-10-29
Report Date	2018-10-30
Date Added to Maude	2018-11-07
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	0
Product Problem Flag	0
Reprocessed and Reused Flag	3
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	0

Device Details

Brand Name	VSI MICRO PUNCTURE KIT 4F
Generic Name	INTRODUCER KIT
Product Code	OFD
Date Received	2018-11-06
Model Number	STIFFEN 7195V
Catalog Number	PN10138
Lot Number	630972
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	DA
Device Eval'ed by Mfgr	I
Device Sequence No	1
Device Event Key	0
Manufacturer	VASCULAR SOLUTIONS, INC.
Manufacturer Address	6464 SYCAMORE CT. N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2018-11-06