SABER014
Report
- Report Number
- 1016427-2026-00015
- Event Type
- Malfunction
- Date Received
- March 9, 2026
- Date of Event
- February 4, 2026
- Report Date
- April 20, 2026
- Manufacturer
- CORDIS US CORP
- Product Code
- LIT
- UDI-DI
- 20705032087640
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, THE 2.5 X 250 .014 SABER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLOON RUPTURED DURING THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE. THE DEVICE WAS RETURNED FOR EVALUATION. ONE NON-STERILE UNIT OF A PTA, OTW, 2.5 × 250, 150 CM WAS RECEIVED INSIDE A CLEAR PLASTIC BAG. THE DEVICE WAS UNPACKED TO PROCEED WITH PRODUCT EVALUATION. UPON VISUAL INSPECTION, THE DEVICE WAS OBSERVED TO BE COILED, AND THE BALLOON WAS FULLY DEFLATED. THE REMAINING COMPONENTS OF THE UNIT WERE ALSO INSPECTED, WITH NO ABNORMALITIES NOTED. THE INFLATION/DEFLATION TEST WAS PERFORMED. DURING FUNCTIONAL TESTING, THE BALLOON WAS ABLE TO BE FULLY INFLATED AND DEFLATED AS INTENDED. THE DEVICE WAS INSPECTED FOR ANY DAMAGE OR ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE, AND NONE WERE OBSERVED ON THE RETURNED DEVICE. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 2506199585 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿BALLOON BURST¿ WAS NOT OBSERVED THROUGH ANALYSIS OF THE RETURNED DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE PASSED FUNCTIONAL ANALYSIS. THE BALLOON WAS INFLATED/DEFLATED WITH NO BURST OR LEAKS NOTED AND WITHOUT ANY ANOMALIES NOTED TO THE BALLOON. THEREFORE, BASED ON THE INFORMATION AVAILABLE FOR REVIEW, IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT REPORTED BY THE CUSTOMER AS NO ANOMALIES WERE NOTED ON THE DEVICE. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH ARE NOT INTENDED TO MITIGATE RISK, ¿CAREFULLY INSPECT THE CATHETER PRIOR TO USE TO VERIFY THAT THE CATHETER HAS NOT BEEN DAMAGED AND THAT ITS SIZE, SHAPE AND CONDITION ARE SUITABLE FOR THE PROCEDURE FOR WHICH IT IS TO BE USED. INFLATION IN EXCESS OF THE RATED BURST PRESSURE MAY CAUSE THE BALLOON TO RUPTURE. USE THE RECOMMENDED BALLOON INFLATION MEDIUM (25% CONTRAST MEDIUM/75% STERILE SALINE SOLUTION). IT HAS BEEN SHOWN THAT A 25/75% CONTRAST / SALINE RATIO HAS YIELDED FASTER BALLOON INFLATION / DEFLATION TIMES. NEVER USE AIR OR OTHER GASEOUS MEDIUM TO INFLATE THE BALLOON. IF RESISTANCE IS STILL FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER, IT IS RECOMMENDED TO REMOVE THE BALLOON CATHETER AND GUIDEWIRE/ INTRODUCER SHEATH AS A SINGLE UNIT. DO NOT CONTINUE TO USE THE BALLOON CATHETER IF THE SHAFT HAS BEEN BENT OR KINKED.¿ NEITHER THE PHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.
THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, THE 2.5 X 250 .014 SABER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLOON RUPTURED DURING THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE OBTAINED AFTER MULTIPLE ATTEMPTS MADE.
AS REPORTED, THE 2.5 X 250 .014 SABER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLOON RUPTURED DURING THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE OBTAINED AFTER MULTIPLE ATTEMPTS MADE.
AS REPORTED, THE 2.5 X 250 .014 SABER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLOON RUPTURED DURING THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE OBTAINED AFTER MULTIPLE ATTEMPTS MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 609080 | SABER014 | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | CORDIS US CORP | 2506199585 | 20705032087640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN. |