SUPERTORQUE 5F MARKER BAND FLUSH CATHETER
Report
- Report Number
- 9616099-2011-00452
- Event Type
- Injury
- Date Received
- June 28, 2011
- Date of Event
- June 2, 2011
- Report Date
- November 4, 2011
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- DQO
- PMA / PMN Number
- K915836
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE THE GOLD MARKERS OF THE SUPERTORQUE PIGTAIL CATHETER DISLODGED AND REMAINED IN THE PATIENT. THE PHYSICIAN PLACED A STENT TO CAGE THEM. THE PROCEDURE WAS TO REPAIR A THORACIC AORTIC ANEURYSM. PATIENT HAD AN AORTOILIAC GRAFT. THE GRAFT REQUIRED DILATING DURING THE PROCEDURE AS IT WAS VERY TIGHT WITH SCAR TISSUE. THEN BALLOON ANGIOPLASTY WAS PERFORMED ON THE AORTOILIAC GRAFT AND THE LEFT ILIAC LIMB. A 24 FRENCH DILATOR WAS INSERTED UP INTO THE AORTA. THE DILATOR WAS REMOVED AND THE SHEATH WAS FLUSHED WITH HEPARINIZED SALINE. THEN THE SURGEON INSERTED THE MAIN DEVICE OVER A LINDQVIST WIRE. IT WAS INSERTED UP TO THE LEFT SUBCLAVIAN. THROUGH THE SAME SHEATH, HE INSERTED A GLIDEWIRE UP TO THE ASCENDING AORTA FOLLOWED BY A SUPERTORQUE PIGTAIL CATHETER. A STENT WAS DEPLOYED. HE REINSERTED THE PIGTAIL CATHETER INTO THE THORACIC AORTA AND PERFORMED AORTIC ARCH ANGIOGRAM. ANOTHER STENT WAS DEPLOYED. COMPLETION ANGIOGRAPHY WAS DONE. IT WAS NOTED THEN THAT THERE WAS AN ABSENCE OF THE MARKERS ON THE SUPERTORQUE PIGTAIL. IT WAS NOTED THAT THE MARKERS HAD ACTUALLY COME OFF THE PIGTAIL CATHETER AND THEY WERE PRESENT IN THE LEFT ILIAC LIMB. OVER A WIRE, THE SURGEON INSERTED A COMPLIANT BALLOON. HE INFLATED THE BALLOON PROXIMALLY AND ATTEMPTED TO BRING THE MARKERS DOWN THROUGH THE LIMB INTO THE SHEATH, HOWEVER, IT SEEMED THAT THEY WERE STUCK AT THE LEVEL OF THE LEFT ILIAC LIMB. SINCE HE COULD NOT RETRIEVE THEM HE DECIDED TO CAGE THEM WITH A STENT IN ORDER TO PREVENT THEM FROM EMBOLIZING. AN 8 X 37 BALLOON EXPANDABLE STENT WAS PLACED IN THE LEFT ILIAC LIMB AFTER ANGIOGRAPHY WAS PERFORMED TO IDENTIFY THE AORTOBI-ILIAC BIFURCATION. THEN THE STENT WAS SUCCESSFULLY DEPLOYED AT 10 ATMOSPHERES. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. ONE NON STERILE 5F DIAGNOSTIC CATHETER 6SH WAS RECEIVED COILED IN A PLASTIC BAG. THE UNIT WAS WITHOUT MARKER BANDS. NO STRETCHING OR ELONGATION MARKS WERE APPRECIATED AT LENGTH CATHETER TIP. SEE PICTURE FOR DETAILS. THE TRACKS OF DISLODGED MARKER BANDS WERE OBSERVED ALONG THE CATHETER TIP, AND SOME GOLDEN RESIDUES ARE ON THE TRACKS AND THIS IS EVIDENCE THAT THE MARKER BAND WAS IN THAT PLACE. THE CATHETER PRESENTS BLOOD RESIDUES. NO ADDITIONAL ANOMALIES WERE FOUND. 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 OUTER DIAMETER (OD) OF THE CATHETER TIP SECTION AND THE DISTANCE BETWEEN EACH MARKER BAND WERE MEASURED, THE OUTER DIAMETERS WERE WITHIN SPECIFICATION, ON THE DISTANCE BETWEEN MARKER BANDS ONLY ON THE FIRST PLACE THE DISTANCE BETWEEN MARKER BANDS (1 & 2) ARE UPPER SPECIFICATION LIMITS AND COINCIDENTALLY HAS THE SMALLER OD MEASURE. THIS ELONGATION COULD BE PRODUCED AFTER A PULL FORCE. THE DISLODGED MARKER BANDS COMPLAINT WAS CONFIRMED, BUT THE EXACT CAUSE OF DISLODGED MARKER BANDS COULD NOT BE CONCLUSIVELY DETERMINED AS MANUFACTURING RELATED FOR THE EVIDENCE THAT EACH MARKER BAND WAS ON THEIR OWN PLACE, AND CONTROLS ARE IN PLACE TO PREVENT THIS KIND OF DEFECTS BEFORE LEAVING THE FACILITY. REFER TO MANUFACTURING WORK INSTRUCTIONS 7-503-161 REV 10, 10087668 REV 7, 10087644 REV 5, 7503167 REV 8, 7503327 REV 24 AND 7-503-187 REV 10. A DPRA WAS INITIATED. THE COMPLAINT OF MARKER BAND DISLODGEMENT WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. ALTHOUGH THE CONFIRMED DAMAGE WAS NOT RELATED TO THE MANUFACTURING PROCESS, A DPRA HAS BEEN OPENED TO ADDRESS THIS TYPE OF FAILURE IN THE PIGTAIL MARKER CATHETERS. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENT.
DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
ACCESS FOR THE PROCEDURE WAS THROUGH A SINGLE LARGE (24F) SHEATH IN THE FEMORAL ARTERY. THE ILIAC ARTERY WAS SEVERELY DISEASED AND FIBROTIC, TO THE EXTENT THAT IT EXERTED EXTERNAL COMPRESSION ON THE SHEATH. SEVERAL DEVICES WERE INTRODUCED THROUGH THE SHEATH SIMULTANEOUSLY, INCLUDING THE DIAGNOSTIC CATHETER OVER A WIRE, AND THE GRAFT INTENDED FOR THE THORACIC AORTA OVER A SECOND WIRE. THE SUPER TORQUE CATHETER WAS SUBJECT TO MUCH GREATER FRICTION THAN USUAL BY VIRTUE OF THE EXTERNAL COMPRESSION AND HAVING MULTIPLE DEVICES IN THE SHEATH AT THE SAME TIME. THE PHYSICIAN BELIEVES THAT MANIPULATION OF THE CATHETER IN THESE SETTINGS LEAD TO DISLODGEMENT OF THE MARKER BANDS. HE HAS CONTINUED USING THE SUPER TORQUE MB ANGIOGRAPHIC CATHETER SINCE, BUT HAS AVOIDED INTRODUCING IT OR ANY DIAGNOSTIC CATHETER SIMULTANEOUSLY THROUGH THE SAME SHEATH AS THE GRAFT. THE PATIENT IS IN GOOD CONDITION WITH NO SEQUELA AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
RISK MANAGER STATED THAT IF THE INITIAL VOLUNTARY MEDWATCH REPORT INDICATED THE DEVICE WAS AVAILABLE FOR ANALYSIS, IT WOULD BE ABLE TO BE RETURNED TO CORDIS FOR EVALUATION. BASED ON THIS, THE FILE WILL REMAIN OPEN PENDING RETURN OF THE DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
DURING PROCEDURE THE GOLD MARKER OF THE SUPERTORQUE CATHETER FELL OFF THE CATHETER AND REMAINED IN THE LEFT ILIAC LIMB OF THE PATIENT. THE PHYSICIAN PLACED A STENT TO CAGE IT. THE PATIENT IS IN GOOD CONDITION. THE PROCEDURE WAS TO REPAIR A THORACIC AORTIC ANEURYSM. PATIENT HAD A AORTOILIAC GRAFT. THE GRAFT REQUIRED DILATING DURING THE PROCEDURE AS IT WAS VERY TIGHT WITH SCAR TISSUE. THEN BALLOON ANGIOPLASTY WAS PERFORMED ON THE AORTOILIAC GRAFT AND THE LEFT ILIAC LIMB. A 24 FRENCH DILATOR WAS INSERTED UP INTO THE AORTA. THE DILATOR WAS REMOVED AND THE SHEATH WAS FLUSHED WITH HEPARINIZED SALINE. THEN THE SURGEON INSERTED THE MAIN DEVICE WHICH WAS INSERTED OVER A LUNDQUIST WIRE. IT WAS INSERTED UNTIL HE GOT DOWN TO THE LEFT SUBCLAVIAN. THROUGH THE SAME SHEATH, HE INSERTED A GLIDEWIRE UP TO THE ASCENDING AORTA FOLLOWED BY A SUPERTORQUE PIGTAIL CATHETER. A STENT WAS DEPLOYED. HE REINSERTED THE PIGTAIL CATHETER BACK INTO THE THORACIC AORTA AND PERFORMED AORTIC ARCH ANGIOGRAM. ANOTHER STENT WAS DEPLOYED. COMPLETION ANGIOGRAPHY WAS DONE. IT WAS NOTED WHEN THAT THERE WAS AN ABSENCE OF THE MARKERS ON THE SUPERTORQUE PIGTAIL. IT WAS NOTED THAT THE MARKINGS HAD ACTUALLY COME OFF THE PIGTAIL CATHETER AND THEY WERE PRESENT IN THE LEFT ILIAC LIMB. OVER A WIRE, THE SURGEON INSERTED A COMPLIANT BALLOON AND THEN A 10 X 4 BALLOON. HE INFLATED THE BALLOON PROXIMALLY AND ATTEMPTED TO BRING THE MARKERS DOWN THROUGH THE LIMB INTO THE SHEATH, HOWEVER, IT SEEMED THAT THEY WERE STUCK AT THE LEVEL OF THE LEFT ILIAC LIMB. SINCE HE COULD NOT RETRIEVE THEM HE DECIDED TO CAGE THEM WITH A STENT IN ORDER TO PREVENT IT FROM EMBOLIZING. AN 8 X 37 BALLOON EXPANDABLE STENT WAS PLACED IN THE LEFT ILIAC LIMB AFTER ANGIOGRAPHY WAS PERFORMED TO IDENTIFY THE AORTO-BI-ILIAC BIFURCATION. THEN THIS WAS BALLOON ANGIOPLASTIED UP TO 10 ATMOSPHERES, SUCCESSFULLY DEPLOYING THIS IN THE LEFT ILIAC LIMB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPERTORQUE 5F MARKER BAND FLUSH CATHETER | DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) | DQO | CORDIS DE MEXICO | NA | 15141473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |