MI,4F,40CM,NIT/SS,7CMSMT
Report
- Report Number
- 2134812-2025-00009
- Event Type
- Malfunction
- Date Received
- April 10, 2025
- Date of Event
- March 19, 2025
- Report Date
- March 19, 2025
- Manufacturer
- VASCULAR SOLUTIONS LLC
- Product Code
- DYB
- UDI-DI
- 108411561072089
- PMA / PMN Number
- K180913
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN #: (B)(4). UDI WILL BE PROVIDED WITH THE FOLLOW UP REPORT.
QN#(B)(4). ONE UNIT OF MIK WAS RETURNED FOR EVALUATION. BLOOD PARTICULATES WERE NOTED ON THE UNIT. UNIT WAS DECONTAMINATED AND INSPECTED. CLEAN SEPARATION OF THE SHAFT WAS OBSERVED FROM MIK HUB. UNIT WAS MANUFACTURED IN TECATE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR LOT 73F2200116. NO ISSUES OR NONCONFORMITIES WERE NOTED. A HISTORICAL REVIEW OF NON-CONFORMANCE RECORDS IDENTIFIED A PREVIOUS NC RELATED TO A HUB MOLDING ISSUE. COMPLAINT DETAILS WERE REVIEWED. CUSTOMER STATED, "DR. (B)(6) HAD THE MICRO PUNCTURE SHEATH IN, WIRE WAS REMOVED SO THAT HE COULD SHOOT CONTRAST, HE INSERTED THE MICRO WIRE AND WHEN HE PULLED THE SHEATH BACK, THERE WAS NO TUBE CONNECTED TO THE HUB OF THE MICRO PUNCTURE SHEATH. HE X-RAYED, AND YOU COULD SEE THAT THE TUBE WAS FULLY SEPARATED." ONE UNIT OF MIK WAS RETURNED FOR EVALUATION. HUB SEPARATION WAS OBSERVED FROM THE SHAFT OF THE SHEATH. THE SEPARATION WAS CLEAN BREAK. ADDITIONAL INFORMATION WAS REQUESTED. A RESPONSE WAS RECEIVED. NO VESSEL TORTUOSITY OR CALCIFICATION NOTED. ENTIRE SHEATH DETACHED FROM THE HUB. HEMOSTATS WERE USED TO GRAB THE LUMEN OF THE SHEATH AND PULLED IT OUT OF PATIENT. PATIENT CONDITION IS FINE. A DHR REVIEW WAS COMPLETED FOR LOT 73F2200116. NO ISSUES OR NON CONFORMITIES WERE NOTED. A HISTORICAL REVIEW OF NON-CONFORMANCE RECORDS IDENTIFIED A PREVIOUS NC RELATED TO A HUB MOLDING ISSUE. CORRECTIVE ACTIONS WERE IMPLEMENTED IN MARCH 2024. THE CURRENT REPORTED COMPLAINT LOT73F2200116 WAS MANUFACTURED IN 2022 PRIOR TO THE IMPLEMENTATION DATE. BASED ON THE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS MAN UFACTURING/PROCESS DEFICIENCY. NO NEW ESCALATION IS DONE AS THE CORRECTIVE ACTIONS WERE IMPLEMENTED IN 2024. THE REPORTED COMPLAINT WAS MANUFACTURED IN 2022. THE DER PROCESS WILL CONTINUE TO MONITOR FOR ANY SIMILAR EVENTS.
IT WAS REPORTED THAT: "DURING THE ACCESS, DR (B)(6) HAD THE MICRO PUNCTURE SHEATH IN, WIRE WAS REMOVED SO THAT HE COULD SHOOT CONTRAST, HE INSERTED THE MICRO WIRE AND WHEN HE PULLED THE SHEATH BACK, THERE WAS NO TUBE CONNECTED TO THE HUB OF THE MICRO PUNCTURE SHEATH. HE X-RAYED, AND YOU COULD SEE THAT THE TUBE WAS FULLY SEPARATED, HE USED A HEMOSTAT TO GRAB THE TUBE THAT HAD BEEN SEPARATED AND WAS ABLE TO PULL IT OUT OF THE PATIENT. THE VESSEL WAS NOT CALCIFIED OR TORTUOUS. HE WAS ABLE TO FINISH THE CASE USING ANOTHER DEVICE. PATIENTS CONDITION IS FINE".
IT WAS REPORTED THAT: "DURING THE ACCESS, DR. (B)(6) HAD THE MICRO PUNCTURE SHEATH IN, WIRE WAS REMOVED SO THAT HE COULD SHOOT CONTRAST, HE INSERTED THE MICRO WIRE AND WHEN HE PULLED THE SHEATH BACK, THERE WAS NO TUBE CONNECTED TO THE HUB OF THE MICRO PUNCTURE SHEATH. HE X-RAYED, AND YOU COULD SEE THAT THE TUBE WAS FULLY SEPARATED, HE USED A HEMOSTAT TO GRAB THE TUBE THAT HAD BEEN SEPARATED AND WAS ABLE TO PULL IT OUT OF THE PATIENT. THE VESSEL WAS NOT CALCIFIED OR TORTUOUS. HE WAS ABLE TO FINISH THE CASE USING ANOTHER DEVICE. PATIENTS CONDITION IS FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 518459 | MI,4F,40CM,NIT/SS,7CMSMT | INTRODUCER, CATHETER | DYB | VASCULAR SOLUTIONS LLC | 73F2200116 | 108411561072089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED| NOT REPORTED |