CROSSER
Received Nov 14, 2025 · Event occurred Oct 10, 2025
Report 2020394-2025-01866 · MDR key 23551257
Device
Generic name
Recanalization Catheter
Manufacturer
Bard Peripheral Vascular, Inc.Catalog number
CRUO14SA
Lot number
GFKQ0175
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Female
- 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 THE CROSSER CATHETER. DURING THE PROCEDURE, THE WIRE PORT ALLEGEDLY DETACHED FROM CATHETER. 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 RETURN OF THE SAMPLE IS PENDING. HOWEVER, PHOTO WAS PROVIDED FOR REVIEW. 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.
Additional Manufacturer Narrative
H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. ONE ELECTRONIC PHOTO WAS RECEIVED AND REVIEWED. THE PHOTO SHOWS THE CROSSER DEVICE WHICH THE GW HUB WAS NOTED TO BE DETACHED, AND THE DETACHED PART WAS PRESENT IN THE PHOTO, AND IT ALSO SHOWS THE PRODUCT LABELLING INFORMATION WHICH DOES MATCH AND VERIFIES WITH TW. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED DETACHMENT AS THE GUIDEWIRE PORT WAS NOTED TO BE DETACHED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DETACHMENT COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. B5, E1, G3, H6 (COMPONENT, METHOD, RESULT, CONCLUSION). SECTION A THROUGH F: THE INFORMATION PROVIDED 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) 2025, A PATIENT PREPPED FOR A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. PRIOR TO THE PROCEDURE, THE WIRE PORT ALLEGEDLY DETACHED FROM CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.