OPTA PRO PTA DILATATION CATHETER
Report
- Report Number
- 9616099-2013-00084
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- January 8, 2013
- Report Date
- January 9, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- LIT
- PMA / PMN Number
- K032737
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE BRAND OF CONTRAST USED WAS OMNIPAQUE 300 AT A 1:1 RATIO. A SPHERE INDEFLATOR FROM COOK WAS USED IN THE PROCEDURE AND WAS SUCCESSFULLY WITH ANOTHER BALLOON. CONCOMITANT DEVICES: CONTRAST: OMNIPAQUE 300; GUIDEWIRE: TERUMO GLIDEWIRE; INDEFLATOR: SPHERE (COOK). ONE NON STERILE CATHETER OPTA PRO 5.0 MM X 8.0 CM 80.0 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS RECEIVED DEFLATED AND APPEAR HAVE BEEN INFLATED. A T BALLOON BURST WAS OBSERVED. 2.5 CM OF BALLOON WAS NOT RECEIVED WITH RETURNED DEVICE. THERE WERE BLOOD RESIDUES OBSERVED IN THE BALLOON. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. LEAK TEST REQUIRED COULD NOT BE PERFORMED DUE TO RECEIVED BALLOON CONDITIONS (T BALLOON BURST). A 0.035" LAB SAMPLE GUIDE WIRE WAS INTRODUCED WITHOUT DIFFICULTY AT THE LUMEN OF THE DISTAL TIP AND RESISTANCE WAS FELT APPROXIMATED AT 10.5 CM FROM DISTAL TIP END DUE TO A KINK IN THE INNER BODY. DIMENSIONAL ANALYSIS FOR DISTAL TIP ID/INNER LUMEN ID COULD BE PERFORMED USING THE PIN GAUGE OF .036" AND THE PIN GAUGE .036" WAS INSERTED IN THE DISTAL TIP ID/ LUMEN INNER ID WITHOUT ANY RESISTANCE. (B)(4). SEM ANALYSIS WAS PERFORMED IN ORDER TO IDENTIFY THE CAUSE OF BALLOON BURST. RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF SCRATCHES AT THE EXTERNAL SURFACE LOCATED AT PROXIMAL BURST SECTION. THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER SURFACE ANOMALIES THAT COULD HAVE CAUSED THE FAILURE. THE MARKER BANDS EXHIBITED NO ANOMALIES. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE BALLOON BURST REPORTED BY THE COSTUMER WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE BALLOON BURST FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THE FAILURE GUIDE WIRE RESISTANCE/FRICTION REPORTED BY THE CUSTOMER WAS CONFIRMED SINCE THE INNER BODY WAS KINKED; HOWEVER, THE EXACT CAUSE OF THE KINK IN THE INNER BODY COULD NOT BE DETERMINED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS, CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS AND KINK IN THE INNER BODY FROM LEAVING THE FACILITY AND NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.
INFORMATION RECEIVED BY AN AFFILIATE INDICATED THAT THERE WAS RESISTANCE/ FRICTION WITH THE GUIDE WIRE WHEN BACK LOADING AN OPTA PRO BALLOON CATHETER 5MM X 80MM, THE DEVICE WAS EVENTUALLY ADVANCED TO THE LESION, INFLATED AND RUPTURED BETWEEN 9 AND 10 ATMS. DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE FROM THE CSI AND THE BALLOON SEPARATED. THE TARGET LESION WAS A 50% STENOSED DIALYSIS SHUNT, DESCRIBED AS NON-CALCIFIED WITH THE STENOSIS LOCATED AT THE DISTAL END OF THE SHUNT IN A BEND. ANGIOGRAPHY WAS PERFORMED AND THE PHYSICIAN DECIDED TO TREAT THE LESION WITH A 5MM X 80MM OPTA PRO BALLOON. THE BALLOON WAS ADVANCED TO THE LESION, LOCATED IN THE U-SHAPE BEND AND INFLATED WHEN IT SUDDENLY BURST. THE STENOSIS THAT WAS TO BE TREATED WAS LOCATED IN THE DISTAL PART OF THE SHUNT, JUST AROUND THE BEND OF THE VESSEL. THE VESSEL WAS STRAIGHT WITH A U-SHAPED BEND AT THE END WITH 50% STENOSIS. THE BALLOON WAS POSITIONED BEFORE, IN AND AFTER THE BEND AND IT THEREFORE FORMED A U-SHAPE. THE (NON-CALCIFIED) STENOSIS WAS LOCATED JUST AFTER THE BEND. THERE WAS SOME RESISTANCE/FRICTION NOTED BETWEEN THE WIRE AND THE DEVICE WHEN LOADING THE DEVICE ONTO THE WIRE, THERE WAS NO FRICTION WITHIN THE SHEATH. AFTER THE BALLOON BURST, DIFFICULTY WAS ENCOUNTERED WITHDRAWING THE DEVICE THROUGH THE SHEATH AND THE BALLOON SEPARATED. UPON INSPECTION OF THE BALLOON, IT BECAME CLEAR THAT THE DISTAL PART OF THE BALLOON HAD RUPTURED, INSTEAD OF A LONGITUDINAL BURST AND IT WAS NOTICED THAT THE RUPTURE OCCURRED MORE DISTAL TO THE STENOSIS. THE MISSING SECTION OF THE BALLOON WAS NOTICED AND ANGIOGRAPHY WAS PERFORMED TO ENSURE THAT NO REMNANTS OF THE BALLOON REMAINED IN THE PATIENT. THE BALLOON COULD BE RETRIEVED WITHOUT FURTHER PROBLEMS AND THE PATIENT WAS SUCCESSFULLY TREATED WITH ANOTHER OPTA PRO BALLOON OF THE SAME SIZE AND OVER THE SAME GUIDEWIRE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER OR DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THERE WAS NO INTRODUCTION DIFFICULTY THROUGH THE SHEATH. THE BRAND OF CONTRAST USED WAS OMNIPAQUE 300 AT A 1:1 RATIO. A SPHERE INDEFLATOR FROM COOK WAS USED IN THE PROCEDURE AND WAS USED SUCCESSFULLY WITH ANOTHER BALLOON. THERE WAS NO REPORT OF PATIENT INJURY AND THE DEVICE WAS RETURNED FOR ANALYSIS. (B)(4): ONE NON STERILE CATHETER OPTA PRO 5.0 MM X 8.0 CM 80.0 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS RECEIVED DEFLATED AND APPEAR HAVE BEEN INFLATED. A T BALLOON BURST WAS OBSERVED. 2.5CM OF BALLOON WAS NOT RECEIVED WITH RETURNED DEVICE. THERE WERE BLOOD RESIDUES OBSERVED IN THE BALLOON. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. A LEAK TEST COULD NOT BE PERFORMED DUE TO RECEIVED BALLOON CONDITIONS. (T BALLOON BURST). A GUIDE WIRE WAS INTRODUCED WITHOUT DIFFICULTY AT THE LUMEN OF THE DISTAL TIP RESISTANCE WAS FELT APPROXIMATED AT 10.5 CM FROM DISTAL TIP END DUE TO A KINK IN THE INNER BODY. DIMENSIONAL ANALYSIS FOR DISTAL TIP ID/INNER LUMEN ID COULD BE PERFORMED USING THE PIN GAUGE OF .036" AND THE PIN GAUGE .036" WAS INSERTED IN THE DISTAL TIP ID/ LUMEN INNER ID WITHOUT ANY RESISTANCE. DIMENSIONAL ANALYSIS FOR OD PROXIMAL SEAL COULD BE PERFORMED USING THE VERNIER A 1.88MM AND THE OD PROXIMAL SEAL WAS FOUND WITHIN SPECIFICATION WITH A MEASURE OF 1.85 MM. DIMENSIONS PROXIMAL SEAL DIAMETER 5F - 1.88 MM. SEM ANALYSIS WAS PERFORMED IN ORDER TO IDENTIFY THE CAUSE OF BALLOON BURST RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF SCRATCHES AT THE EXTERNAL SURFACE LOCATED AT PROXIMAL BURST SECTION. THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER SURFACE ANOMALIES THAT COULD HAVE CAUSED THE FAILURE. THE MARKER BANDS EXHIBITED NO ANOMALIES. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED CUSTOMER COMPLAINT OF BALLOON BURST, SEPARATION AND RESISTANCE/FRICTION WITH THE GUIDE WIRE LUMEN WERE CONFIRMED THROUGH FAILURE ANALYSIS. THE REPORTED CUSTOMER COMPLAINT OF WITHDRAWAL DIFFICULTY THROUGH THE SHEATH COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE RECEIVED DEVICE. REVIEW OF THE ANALYSIS INDICATED EVIDENCE OF ABRASIONS ON THE EXTERNAL SURFACE OF THE BALLOON NEAR THE PROXIMAL SECTION OF THE BURST; THIS IS SUGGESTIVE OF THE BALLOON ENCOUNTERING A ROUGH SURFACE THAT MAY HAVE CONTRIBUTED TO THE BURST. THE BALLOON SEPARATION MAY HAVE BEEN RELATED TO THE DIFFICULTY ENCOUNTERED WHEN ATTEMPTING TO WITHDRAW THE DEVICE. THE ANALYSIS ALSO INDICATED THAT THERE WAS A KINK ON THE DEVICE LIKELY CONTRIBUTING TO THE RESISTANCE/FRICTION ENCOUNTERED WITH THE GUIDE WIRE. THE SOURCE OF THE KINK COULD NOT BE DETERMINED. REVIEW OF THE INFORMATION PROVIDED AND THE DEVICE ANALYSIS SUGGESTS THAT LESION CHARACTERISTICS (LESION LOCATED IN A U-SHAPE BEND AND SURFACE ABRASIONS ON THE BALLOON) MAY HAVE LEAD TO THE DIFFICULTIES ENCOUNTERED BY THE CUSTOMER. THERE IS NOTHING IN THE ANALYSIS OR THE DEVICE HISTORY REPORT REVIEW TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.
THE REPORT RECEIVED INDICATED THAT THERE WAS RESISTANCE WHEN BACKLOADING A 5 MM X 80 MM ON 80 CM SHAFT OPTA PRO BALLOON CATHETER WHICH ALSO RUPTURED BETWEEN 9 AND 10 ATM AND ANALYSIS OF THE DEVICE INDICATED THAT "2.5 CM OF BALLOON WAS NOT RECEIVED". THERE WAS ALSO DIFFICULTY REMOVING THE DEVICE FROM THE CSI. AFTER ASSESSING THE CONTRAST IMAGES, THE PHYSICIAN DECIDED TO PERFORM A PTA OF A NATIVE DIALYSIS SHUNT (ARM) WITH THE OPTA PRO SELECTED. WHILE BACKLOADING THE BALLOON ON A TERUMO GLIDEWIRE (AND THROUGH A CORDIS BRITE TIP SHEATH) THE PHYSICIAN FELT RESISTANCE SOMEWHERE AT THE LEVEL OF THE BALLOON ITSELF. STILL, HE WAS ABLE TO ADVANCE THE BALLOON AND TO BRING IT INTO POSITION FOR DILATATION. THE STENOSIS THAT WAS TO BE TREATED WAS LOCATED IN THE DISTAL PART OF THE SHUNT, JUST AROUND THE BEND OF THE VESSEL. THE VESSEL WAS STRAIGHT WITH A U-SHAPED BEND AT THE END WITH 50% STENOSIS. THE BALLOON WAS POSITIONED BEFORE, IN AND AFTER THE BEND AND IT THEREFORE FORMED A U-SHAPE. THE (NON-CALCIFIED!) STENOSIS WAS LOCATED JUST AFTER THE BEND. DURING INFLATION NOTHING SPECIAL WAS NOTICED, UNTIL THE BALLOON SUDDENLY RUPTURED SOMEWHERE BETWEEN 9 AND 10 ATM. THE BALLOON COULD BE RETRIEVED WITHOUT FURTHER PROBLEMS AND THE PATIENT WAS SUCCESSFULLY TREATED WITH ANOTHER OPTA PRO BALLOON IN THE SAME SIZE AND OVER THE SAME GUIDEWIRE. UPON INSPECTION OF THE BALLOON, IT BECAME CLEAR THAT THE DISTAL PART OF THE BALLOON HAD RUPTURED, INSTEAD OF A LONGITUDINAL BURST. ALSO, THE RUPTURE WAS MORE DISTALLY THAN THE STENOSIS. THE MISSING BALLOON OF THE BALLOON WAS NOTICED BEFORE. HOWEVER, ANGIO HAS BEEN PERFORMED TO CHECK IF NO MATERIAL WAS LEFT BEHIND IN PATIENT AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, ANY DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER OR ANY DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77721 | OPTA PRO PTA DILATATION CATHETER | PTA CATHETERS (LIT) | LIT | CORDIS DE MEXICO | NA | 15620985 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |