SABERX014
Report
- Report Number
- 1016427-2025-00071
- Event Type
- Malfunction
- Date Received
- August 22, 2025
- Date of Event
- July 23, 2025
- Report Date
- September 19, 2025
- Manufacturer
- CORDIS CORPORATION
- Product Code
- LIT
- UDI-DI
- 20705032089521
- PMA / PMN Number
- K221832
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AS REPORTED, THE 2.0 X 250 .014 SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WOULD NOT CROSS THE LESION. WHEN BALLOON WAS BEING REMOVED THE SHAFT BROKE AS IT WAS COMING OUT THE SHEATH. THE SHAFT BROKE INTO TWO SEPARATE PIECES. THE CASE WAS COMPLETED USING AN ALTERNATIVE NON-CORDIS BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THE PHYSICIAN WAS ATTEMPTING TO TREAT TIBIAL LESION FROM CONTRALATERAL ACCESS. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE SHIPPING STYLET AND BALLOON COVER WERE REMOVED BEFORE SUBMERGING IN HEPARINIZED SALINE SOLUTION. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY DURING PREP. THE DEVICE PREPPED NORMALLY AND MAINTAINED NEGATIVE PRESSURE. THE TARGET LESION WAS LOCATED IN THE TIBIAL VESSEL. AT THE TARGET SITE, THE VESSEL WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS, WITH 100% STENOSIS. THE DEVICE WAS BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS RETURNED FOR EVALUATION. A NON-STERILE ¿PTA, RX, 2.0 X 250, 200 CM¿ DEVICE WAS RECEIVED COILED INSIDE A CLEAR PLASTIC BAG. THE PRODUCT WAS UNPACKED FOR EVALUATION. A SHAFT SEPARATION WAS OBSERVED APPROXIMATELY 126 CM FROM THE DISTAL TIP. THE PROXIMAL SEPARATED SECTION SHOWED MULTIPLE KINKS AT APPROXIMATELY 18, 31, 41, 67, AND 81 CM FROM THE PROXIMAL END. THE DISTAL SEPARATED SECTION ALSO PRESENTED KINKS LOCATED AT APPROXIMATELY 51, 77, 102, AND 125 CM FROM THE DISTAL TIP. THE BALLOON WAS RETURNED DEFLATED AND UNDAMAGED. NO ADDITIONAL ABNORMALITIES WERE NOTED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DEVICE¿S CONDITION AND THE NATURE OF THE COMPLAINT. THE SEPARATION SITE WAS EXAMINED USING A VISION SYSTEM. ELONGATIONS WERE OBSERVED ON BOTH EDGES OF THE OUTER SHAFT, WHILE PLASTIC DEFORMATION AND FATIGUE LINES WERE NOTED ON THE INNER SHAFT. THESE FEATURES ARE CONSISTENT WITH MATERIAL TENSILE OVERLOAD. BASED ON THESE FINDINGS, IT IS CONCLUDED THAT THE DEVICE WAS SUBJECTED TO A TENSILE FORCE EXCEEDING THE MATERIAL¿S YIELD STRENGTH PRIOR TO SEPARATION. THE REPORTED ¿PTA/PTCA SYSTEM FAILURE TO CROSS¿ CANNOT BE VERIFIED AS IT CANNOT BE REPLICATED IN A LAB SETTING. DIFFICULTY CROSSING A LESION, ANATOMICAL STRUCTURE, OR STENT IS A KNOWN PROCEDURAL OCCURRENCE, OFTEN RELATED TO PATIENT ANATOMY, OPERATOR TECHNIQUE, AND DEVICE SELECTION. THE REPORTED ¿BODY/SHAFT SEPARATED¿ WAS OBSERVED AS THE DEVICE WAS RECEIVED IN TWO PIECES. BASED ON THE PRODUCT EVALUATION AND THE REPORTED EVENT, THE DEVICE SEPARATION WAS MOST LIKELY CAUSED BY EXCESSIVE TENSILE FORCES APPLIED DURING ATTEMPTED WITHDRAWAL OF THE BALLOON ACROSS A MODERATELY CALCIFIED, TORTUOUS TIBIAL VESSEL WITH 100% STENOSIS. THE PRESENCE OF MULTIPLE KINKS AND SHAFT SEPARATION, ALONG WITH ELONGATIONS, PLASTIC DEFORMATION, AND FATIGUE LINES OBSERVED IN THE INNER SHAFT, ARE CONSISTENT WITH TENSILE OVERLOAD BEYOND THE MATERIAL¿S YIELD STRENGTH. ALTHOUGH THE DEVICE WAS PREPARED AND HANDLED ACCORDING TO THE IFU AND NO PRE-USE ABNORMALITIES WERE NOTED, THE CHALLENGING ANATOMY AND RESISTANCE AT THE LESION SITE LIKELY CONTRIBUTED TO INCREASED STRESS ON THE SHAFT, ULTIMATELY RESULTING IN FRACTURE DURING REMOVAL. 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. FLUSH OR RINSE ALL PRODUCTS ENTERING THE VASCULAR SYSTEM WITH STERILE ISOTONIC SALINE OR A SIMILAR SOLUTION VIA THE GUIDE-WIRE ACCESS PORT PRIOR TO USE. NEVER ATTEMPT TO MOVE THE GUIDE WIRE WHEN THE BALLOON IS INFLATED. DO NOT ADVANCE THE CATHETER AGAINST SIGNIFICANT RESISTANCE. THE CAUSE OF RESISTANCE SHOULD BE DETERMINED VIA FLUOROSCOPY. IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER THROUGH THE INTRODUCER SHEATH, DETERMINE IF CONTRAST IS TRAPPED IN THE BALLOON WITH FLUOROSCOPY. IF CONTRAST IS PRESENT, PUSH THE BALLOON OUT OF THE SHEATH AND THEN COMPLETELY EVACUATE THE CONTRAST BEFORE PROCEEDING TO WITHDRAW 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.¿ BASED ON THE INFORMATION AVAILABLE AND PRODUCT ANALYSIS, THERE IS NO 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 2.0 X 250 .014 SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WOULD NOT CROSS THE LESION. WHEN BALLOON WAS BEING REMOVED THE SHAFT BROKE AS IT WAS COMING OUT THE SHEATH. THE SHAFT BROKE INTO TWO SEPARATE PIECES. THE CASE WAS COMPLETED USING AN ALTERNATIVE NON-CORDIS BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THE PHYSICIAN WAS ATTEMPTING TO TREAT TIBIAL LESION FROM CONTRALATERAL ACCESS. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE SHIPPING STYLET AND BALLOON COVER WERE REMOVED BEFORE SUBMERGING IN HEPARINIZED SALINE SOLUTION. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY DURING PREP. THE DEVICE PREPPED NORMALLY AND MAINTAINED NEGATIVE PRESSURE. THE TARGET LESION WAS LOCATED IN THE TIBIAL VESSEL. AT THE TARGET SITE, THE VESSEL WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS, WITH 100% STENOSIS. THE DEVICE WAS BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WILL BE RETURNED FOR EVALUATION.
AS REPORTED, THE 2.0 X 250 .014 SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WOULD NOT CROSS THE LESION. WHEN BALLOON WAS BEING REMOVED THE SHAFT BROKE AS IT WAS COMING OUT THE SHEATH. THE SHAFT BROKE INTO TWO SEPARATE PIECES. THE CASE WAS COMPLETED USING AN ALTERNATIVE NON-CORDIS BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THE PHYSICIAN WAS ATTEMPTING TO TREAT TIBIAL LESION FROM CONTRALATERAL ACCESS. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE SHIPPING STYLET AND BALLOON COVER WERE REMOVED BEFORE SUBMERGING IN HEPARINIZED SALINE SOLUTION. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY DURING PREP. THE DEVICE PREPPED NORMALLY AND MAINTAINED NEGATIVE PRESSURE. THE TARGET LESION WAS LOCATED IN THE TIBIAL VESSEL. AT THE TARGET SITE, THE VESSEL WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS, WITH 100% STENOSIS. THE DEVICE WAS BEING USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2395394 | SABERX014 | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | CORDIS CORPORATION | 2304174465 | 20705032089521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |