MalfunctionDRC
WINGED GUIDEWIRE INTRODUCER NEEDLE 18GA X 7CM
Received Jul 6, 2026
Report 0001625425-2026-00982 · MDR key 25713303
Device
Product problems
- Dull, Blunt
Patient
NA · Unknown
- Syncope/Fainting
Narrative
Additional Manufacturer Narrative
IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.
Description of Event or Problem
PERFORATION OF THE BLOOD VESSEL CAUSED BY A BLUNT NEEDLE TIP. AS A RESULT, THE PATIENT EXPERIENCED A VAGAL REACTION ACCOMPANIED BY SYNCOPE. DOCTORS COMMENT: THE NEEDLE TIP IS NOT SHARP ENOUGH, WHICH MEANS IT IS SOMETIMES NOT POSSIBLE TO PUNCTURE THE JUGULAR VEIN.