POWERFLEX PRO
Report
- Report Number
- 3007635982-2024-00170
- Event Type
- Malfunction
- Date Received
- July 1, 2024
- Date of Event
- June 3, 2024
- Report Date
- August 12, 2024
- Manufacturer
- CORDIS US. CORP
- Product Code
- LIT
- UDI-DI
- 10705032059237
- PMA / PMN Number
- K112797
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTED DATA: UPDATED PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: D4, G3, G6, H1, H2, H3, H6, AND H10. COMPLAINT CONCLUSION: AS REPORTED, THE BALLOON ON 4MM X 12CM X 135 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS FOUND TO BE LEAKING. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS NOT USED INSIDE OF THE PATIENT. THE DEVICE WAS RETURNED FOR EVALUATION. A NON-STERILE ¿POWERFLEXPRO 4MM12CM 135¿ WAS RECEIVED FOR ANALYSIS COILED INSIDE OF A CLEAR PLASTIC BAG. THE DEVICE WAS UNPACKED AND PLACED ON A METALLIC TRAY FOR INSPECTION. A THOROUGH CHECK REVEALED NO DAMAGES OR ANOMALIES. NO OTHER NOTABLE DETAILS WERE OBSERVED. A FUNCTIONAL TEST WAS CONDUCTED USING AN INFLATOR/DEFLATOR DEVICE ATTACHED TO THE INFLATION PORT. POSITIVE PRESSURE WAS APPLIED TO REACH THE RATED BURST PRESSURE. HOWEVER, THE INFLATION PRESSURE WAS NOT MAINTAINED DUE TO A LEAK IN THE BALLOON. THE VISION SYSTEM INSPECTION REVEALED A RUPTURE ON THE BALLOON¿S SURFACE WHERE WATER WAS LEAKING. THE SURFACE SHOWED SIGNS OF RUPTURE AND SECONDARY SCRATCH MARKS NEAR THE DAMAGED AREA, LIKELY CAUSED BY INTERACTION WITH A SHARP OBJECT OR MECHANICAL DAMAGE. THE SAME FACTORS THAT CAUSED THE SCRATCH MARKS PROBABLY LED TO THE DAMAGE OBSERVED ON THE DEVICE, INDICATING THE MATERIAL NEAR THE DAMAGED AREA WAS AFFECTED BY A SHARP OBJECT FROM THE OUTSIDE. SEM ANALYSIS WAS NOT PERFORMED AS THE DAMAGES ASSOCIATED WITH THE LEAKAGE ARE VISIBLE WITH THE MAGNIFICATION OBTAINED WITH A VISION SYSTEM. THE REPORTED ¿BALLOON LEAKAGE¿ WAS CONFIRMED AS A LEAKAGE WAS NOTED DURING FUNCTIONAL ANALYSIS. HOWEVER, THE EXACT CAUSE OF THE LEAKAGE COULD NOT BE DETERMINED. THE BALLOON SURFACE SHOWED SIGNS OF RUPTURE AND SECONDARY SCRATCH MARKS NEAR THE DAMAGED AREA, LIKELY CAUSED BY INTERACTION WITH A SHARP OBJECT OR MECHANICAL DAMAGE FROM THE OUTSIDE. THEREFORE, BASED ON THE INFORMATION AVAILABLE FOR REVIEW, PROCEDURAL FACTORS DURING DEVICE PREPARATION MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿FLUSH THE ¿THRU¿ LUMEN WITH STERILE HEPARINIZED SALINE OR A SIMILAR ISOTONIC SOLUTION. PLACE THE PREPARED CATHETER OVER A PREPOSITIONED GUIDEWIRE AND ADVANCE THE TIP TO THE INTRODUCTION SITE. NOTE: BALLOON INFLATION SHOULD BE PERFORMED WITH THE GUIDEWIRE EXTENDED BEYOND THE CATHETER TIP. IT IS STRONGLY RECOMMENDED THAT THE GUIDEWIRE, THE BALLOON CATHETER, OR BOTH, REMAIN ACROSS THE LESION UNTIL THE PROCEDURE IS COMPLETE AND THE DILATATION SYSTEM IS TO BE REMOVED FROM THE VESSEL. NOTE: TO PRESERVE THE FOLDED BALLOON SHAPE DURING INSERTION AND CATHETER MANIPULATION, MAINTAIN A VACUUM ON THE INFLATION LUMEN. CAUTION: FULLY DEFLATE THE BALLOON BY INDUCING NEGATIVE PRESSURE WITH THE INFLATION SYSTEM WHENEVER THE PTA CATHETER IS ADVANCED OR WITHDRAWN. DO NOT ADVANCE OR WITHDRAW THE PTA CATHETER WITHIN THE VASCULATURE UNLESS THE CATHETER IS PRECEDED BY A GUIDEWIRE. CAREFULLY ADVANCE THE CATHETER THROUGH A SHEATH OR GUIDE CATHETER THROUGH THE PERCUTANEOUS ENTRY SITE. NOTE: GENTLE COUNTERCLOCKWISE ROTATION OF THE BALLOON MAY EASE INTRODUCTION THROUGH THE SHEATH OR PERCUTANEOUS ENTRY SITE. NOTE: PERFORM ALL FURTHER CATHETER MANIPULATIONS UNDER FLUOROSCOPY. CAREFULLY ADVANCE THE CATHETER TO THE SELECTED STENOSIS. CAUTION: IF STRONG RESISTANCE IS MET DURING ADVANCEMENT OR WITHDRAWAL OF THE CATHETER, DISCONTINUE MOVEMENT AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE ENTIRE SYSTEM. USING FLUOROSCOPY AND THE RADIOPAQUE MARKER BANDS, POSITION THE CATHETER AT THE APPROPRIATE LOCATION. WHEN AN ACCEPTABLE POSITION HAS BEEN OBTAINED, INFLATE THE BALLOON TO ACHIEVE THE DESIRED DILATATION. CAUTION: DO NOT EXCEED THE RATED BURST PRESSURE. HIGHER PRESSURES MAY DAMAGE THE BALLOON OR CATHETER OR OVER DISTEND THE SELECTED ARTERY. WARNING: INFLATION AT A HIGH RATE MAY DAMAGE THE BALLOON.¿ THE INFORMATION AVAILABLE DOES NOT SUGGEST 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. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, THE BALLOON ON 4MM X 12CM X 135 POW4ERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS FOUND TO BE LEAKING DURING USE. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS NOT USED INSIDE OF THE PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1270308 | POWERFLEX PRO | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | CORDIS US. CORP | NA | 82278860 | 10705032059237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |