LitePac RX PTA Catheter
Received Jun 29, 2026 · Event occurred Jun 8, 2026
Report 9616666-2026-00156 · MDR key 25649356
Device
Generic name
Pta Balloon Dilatation Catheter
Manufacturer
Clearstream Technologies Ltd.Catalog number
68202127
Lot number
CMKX0273
Product problems
- Break
- Fracture
- Inflation Problem
- Leak/Splash
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2026, A PATIENT UNDERWENT BALLOON ANGIOPLASTY PROCEDURE USING A LITEPAC DEVICE. DURING THE PROCEDURE, THE BALLOON WAS OBSERVED TO BE LEAKING AND COULD NOT BE INFLATED PROPERLY; ADDITIONALLY, THE PROXIMAL CONNECTION OF THE BALLOON WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Additional Manufacturer Narrative
H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE SLEEK RX PTA CATHETER PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE SLEEK RX PTA CATHETER PRODUCTS ARE IDENTIFIED IN D2 AND G4. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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.