FDA Adverse Event
Injury
Summary report: N
MI,4FST,40CM,SS/TUN,7ECO
MDR report key: 24660110
·
Received March 23, 2026
Report
- Report Number
- 2134812-2026-00010
- Event Type
- Injury
- Date Received
- March 23, 2026
- Date of Event
- February 25, 2026
- Report Date
- February 25, 2026
- Manufacturer
- VASCULAR SOLUTIONS LLC
- Product Code
- OFC
- UDI-DI
- 10841156102876
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
QN# (B)(4). COMPLAINT DETAILS WERE REVIEWED. CUSTOMER STATED, " 4F MIK SHEATH SEPARATED FROM HUB UPON REMOVAL". NO UNIT WAS RETURNED FOR EVALUATION. IT IS UNKNOWN TO WHAT EXTENT AND DEGREE OF DAMAGE WAS PRESENT ON THE UNIT. ADDITIONAL INFORMATION WAS REQUESTED. A RESPONSE WAS RECEIVED. SURGICAL CUTDOWN WAS EMPLOYED TO REMOVE THE SHEATH. BASED ON THE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS UNDETERMINABLE. TELEFLEX WILL CONTINUE TO MONITOR SIMILAR ISSUES AND TRENDS.
Description of Event or Problem · 0
IT WAS REPORTED THAT: "4F MIK SHEATH SEPARATED FROM HUB UPON REMOVAL. A CUTDOWN WAS PERFORMED TO REMOVE REMAINDER OF DEVICE."
Description of Event or Problem · 0
IT WAS REPORTED THAT: "4F MIK SHEATH SEPARATED FROM HUB UPON REMOVAL. A CUTDOWN WAS PERFORMED TO REMOVE REMAINDER OF DEVICE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287471 | MI,4FST,40CM,SS/TUN,7ECO | INTRODUCER, CATHETER | OFC | VASCULAR SOLUTIONS LLC | 73J2500573 | 10841156102876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |