CROSSER IQ
Received Sep 23, 2025 · Event occurred Sep 1, 2025
Report 2020394-2025-01547 · MDR key 23120426
Device
Generic name
Recanalization Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
XCTO146
Lot number
GFKR1649
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING CROSSER CATHETER. DURING THE PROCEDURE, THE TIP OF THE CATHETER ALLEGEDLY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.
Additional Manufacturer Narrative
H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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.