KELLYWICK TUNNELER
Received Jul 3, 2026 · Event occurred Jun 5, 2026
Report 2020394-2026-01711 · MDR key 25702331
Device
Generic name
Surgical Other
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
KW2000
Lot number
UNKNOWN
Product problems
- Tear, Rip or Hole in Device Packaging
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
Description of Event or Problem
ON (B)(6) 2026, A PATIENT UNDERWENT SURGICAL PROCEDURE USING A KELLY WICK TUNNELLER. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THERE WAS BENT ON LATCH AND HOLES IN THE INTERNAL PLASTIC. THERE WAS NO PATIENT CONTACT.