ETS FLEX ARTICNG
Report
- Report Number
- 3005075853-2010-04778
- Event Type
- Death
- Date Received
- August 23, 2010
- Date of Event
- July 28, 2010
- Report Date
- July 29, 2010
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). INSTRUMENT B: BATCH #: G5ZE0D, EXP DATE: 05/01/2015' MFR DATE: 06/01/2010 THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE A WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE RELOAD WAS LOADED ON THE DEVICE WITHOUT ANY DIFFICULTIES NOTED AND DID NOT FELL OUT DURING THE FUNCTIONAL TEST. THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE B WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE RELOAD WAS LOADED ON THE DEVICE WITHOUT ANY DIFFICULTIES NOTED AND DID NOT FELL OUT DURING THE FUNCTIONAL TEST. THE EVENT DESCRIPTION AND NOTES INDICATES THE POTENTIAL FOR AN IMPROPERLY INSTALLED CARTRIDGE; EITHER THE CARTRIDGE IS NOT FULLY INSERTED INTO THE CHANNEL OR IT IS "LONG LOADED". IF "LONG LOADED" THE CARTRIDGE EXTENDS BEYOND THE CARTRIDGE JAWS FURTHER THAN IT SHOULD (HOLDING FEATURES OF THE CARTRIDGE ARE NOT SNAPPED INTO THE CHANNEL SLOTS AND THE HOLDING FEATURES ARE IN FRONT OF THE CHANNEL). IF THE CARTRIDGE IS NOT PROPERLY SNAPPED INTO THE CHANNEL OR IS "LONG LOADED" THE CARTRIDGE CAN MOVE FORWARD DURING THE FIRING STROKE AND SOME STAPLES MAY BE DEPLOYED, THE DEVICE WILL CONTINUE TO CUT, AND THE CARTRIDGE MAY BE PUSHED OUT. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.
(B)(4). ADDITIONAL FOLLOWUP: SPOKE WITH EES SALES REP, SHE INDICATED THAT THE FIRST DEVICE MALFUNCTIONED (NO DETAILS), THE SECOND DEVICE WAS CLOSED FIRED AND UPON OPENING BLOOD WAS PRESENT EVERYWHERE. IT IS UNSURE WHAT FIRING THIS OCCURRED. MORE THAN 2 RELOADS WERE USED IN THE CASE. THE SURGEON HAS BEEN USING THE DEVICE FOR 2-3 YEARS. NO FURTHER INFORMATION IS KNOWN FROM THE REP. EES MEDICAL DIRECTOR SPOKE WITH OPERATING SURGEON: THIS WAS A ELDERLY MALE PATIENT, WHO HAD RECENTLY HAD AN ACUTE MI AND WAS STENTED, DURING THAT ILLNESS HE WAS FOUND TO HAVE, A LONG LIST OF PROBLEMS, INCLUDING CRITICAL AORTIC STENOSIS AND A BULKY LUL LUNG MASS. THE SURGEON WAS PERFORMING THE LOBECTOMY THROUGH MINIMALLY INVASIVE TECHNIQUES. HE WAS TAKING DOWN THE SEGMENTAL BRANCHES OF THE LEFT UPPER LOBE. DURING THE SECOND FIRING OF THE DEVICE, HIS WELL-EXPERIENCED FIRST ASSISTANT ACTUALLY PULLED THE HANDLE WHILE HE STABILIZED THE SHAFT OF THE DEVICE. NEITHER HE, NOR SHE, NOTED, ANYTHING FANCY OR ALARMING. UNFORTUNATELY, WHEN THE DEVICE WAS OPENED THEY ENCOUNTERED VIGOROUS BLEEDING. THE CHEST WAS OPENED, A CLAMP APPLIED (HE HAD NOT OBTAINED PROXIMAL CONTROL PRIOR TO THE USE OF THE STAPLER) AND CARDIAC MASSAGE BEGUN. THE PATIENT EXPIRED ON THE TABLE, PROBABLY DUE TO HIS CORONARY DISEASE AND AORTIC STENOSIS, SURGEON BELIEVES. WHEN INSPECTING THE CHEST WOUND, IT WAS NOTED THAT THE CARTRIDGE IN QUESTION WAS LYING IN THE CHEST WALL, DISLODGED FROM THE STAPLER. HE HAS NO RECOLLECTION OF WHEN OR HOW THAT OCCURRED, THOUGH HE DOES INSERT THE STAPLER DIRECTLY THROUGH THE CHEST WALL AND NOT THROUGH A TROCAR. IT APPEARED TO SOMEONE WHO LOOKED AT THE CARTRIDGE, THAT ABOUT HALF OF THE STAPLES HAD BEEN FIRED. HE WAS ALSO ABLE TO EXAMINE THE BLEEDING PULMONARY VEIN, AND IT APPEARED HERE TOO THAT ONLY ABOUT HALF OF THE STAPLES HAD BEEN FIRED. THERE WERE NO HEMOCLIPS USED DURING THE CASE, AND THE FIRST FIRING OF THE STAPLER WAS WELL AWAY FROM THIS STAPLE USE. THE STAFF PERSON LOADING THE INSTRUMENT WAS APPARENTLY WELL EXPERIENCED ACCORDING TO THE SURGEON. " THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS.
(B)(4). SPRING CARTRIDGE LOCKOUT TAB THE ANALYSIS RESULTS FOUND THAT TWO (B)(4) RELOADS WERE RECEIVED. RELOAD A WAS RECEIVED FULLY FIRED AND WITH THE LOCKOUT DAMAGED. RELOAD B WAS RECEIVED PARTIALLY FIRED AND WITH DAMAGE TO THE SPRING CARTRIDGE LOCKOUT. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED RELOADS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.
IT WAS REPORTED THAT PRIOR TO A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE JAWS OF DEVICE WOULD NOT OPEN. THE PROBLEM OCCURRED DURING INSPECTION OF DEVICE BY THE SURGEON, PRIOR TO USE ON PATIENT. A SECOND DEVICE WAS FOUND TO HAVE THE SAME PROBLEM. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. TWO DEVICES WILL BE RETURNED.
IT WAS INITIALLY REPORTED THAT DURING VIDEO ASSISTED THORACIC PROCEDURE THE SURGEON FIRED THE FIRST DEVICE AND THE DEVICE MALFUNCTIONED. A SECOND DEVICE WAS PULLED. THE SURGEON CLOSED THE DEVICE AND THE DEVICE WAS FIRED. WHEN THE DEVICE WAS OPENED THERE WAS BLOOD EVERYWHERE. THE ACCOUNT STATED THAT THE STAPLES SHOT OUT OF THE DEVICE AND CUT THE PULMONARY ARTERY. THE PATIENT'S BLOOD PRESSURE DROPPED AND THEY WERE GIVEN 11 UNITS OF BLOOD. THE SURGEON COULD NOT CONTROL THE BLEEDING. THE PATIENT DIED. ONE OF THE CARTRIDGES WAS PARTIALLY FIRED AND THE OTHER WAS COMPLETELY FIRED. UNKNOWN WHICH CARTRIDGE WAS USED IN THE DEVICE OR WHAT FIRINGS.
THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING PCI OF A 99% DE NOVO LESION IN THE DISTAL RCA THAT WAS SLIGHTLY CALCIFIED AND HIGHLY TORTUOUS, A 3.5X18MM CYPHER BX WAS DELIVERED TO THE TARGET LESION WITHOUT FRICTION AND WHEN BEING INFLATED UP TO 8 ATM, THE BALLOON RUPTURED. THE LESION HAD BEEN PRE-DILATED WITH A LACROSSE BALLOON CATHETER. BALLOON RUPTURE OF THE CYPHER BALLOON CATHETER WAS CONFIRMED BY DECREASING PRESSURE OF THE INFLATION DEVICE. THEREFORE, THE SDS OF THE CYPHER BX WAS RETRIEVED FROM THE PATIENT AND POST-DILATION WAS CONDUCTED WITH A LIFESPEAR BALLOON CATHETER AT 16ATM TO FURTHER DILATE THE CYPHER BX STENT. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. THE PHYSICIAN COMMENTED THAT THERE WAS NO DIFFICULTY DELIVERING THE CYPHER BX AND THE BALLOON CATHETER FOR THE PRE-DILATION HAD NO PROBLEM AND SO THERE MIGHT HAVE BEEN EFFECT OF THE STENT STRUT DUE TO THE FLEXED LESION, BUT THE CAUSE OF THE BALLOON RUPTURE WAS UNKNOWN BECAUSE THE BALLOON CATHETER FOR THE POST-DILATION HAD NO PROBLEM. THE EXACT RATIO OF CONTRAST IS UNKNOWN BUT IT IS USUALLY 1:1. AN INDEFLATOR OF UNKNOWN BRAND WAS USED AND WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO DIFFICULTY ADVANCING THE CATHETER THROUGH THE VESSEL OR CROSSING THE LESION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS FLEX ARTICNG | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |