ECLIPSE2L BALLOON CATHETER
Report
- Report Number
- 3014162263-2022-00006
- Event Type
- Malfunction
- Date Received
- February 24, 2022
- Date of Event
- January 26, 2022
- Report Date
- March 28, 2022
- Manufacturer
- BALT USA
- Product Code
- MJN
- UDI-DI
- 00818053022944
- PMA / PMN Number
- K183045
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BALT USA'S REFERENCE NUMBER: (B)(4). PENDING INVESTIGATION RESULTS FROM SUPPLIER BALT EXTRUSION. 13FEB2022- ISSUER REVEALED THAT THE HOSPITAL WOULD NOT BE RELEASING THE PRODUCT FOR ANALYSIS. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OF THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
BALT USA'S REFERENCE NUMBER: (B)(4). 13FEB2022- ISSUER REVEALED THAT THE HOSPITAL WOULD NOT BE RELEASING THE PRODUCT FOR ANALYSIS. THE PRODUCT WAS NOT AVAILABLE FOR ANALYSIS DESPITE ATTEMPTS MADE BY BALT USA. SUPPLIER BALT EXTRUSION PROVIDED THEIR INVESTIGATION OF THE REPORTED ISSUE, SUMMARY PROVIDED AS FOLLOWS: THE AFFECTED CATHETER ECLIPSE2L HAS NOT BEEN RETURNED TO BALT EXTRUSION SAS FOR INSPECTION. AS A RESULT, THE ANALYSIS OF THE REPORTED EVENT WAS LIMITED. THE REVIEW WAS BASED ON THE INCIDENT DESCRIPTION, THE DEVICE HISTORY RECORDS AND THE DATA GATHERED DURING OUR POST-MARKETING SURVEILLANCE PROGRAM FOR SUCH FAILURES. THE REVIEW OF THE LOT HISTORY RECORDS (LHRS) FOR THIS SPECIFIC BATCH NUMBERS DID NOT HIGHLIGHT ANY ANOMALY DURING THE MANUFACTURING PROCESS. SEVERAL TESTS WERE PERFORMED DURING THE MANUFACTURING PROCESS: THE BRAID, THE TUBE, AND THE BALLOON ARE 100% CONTROLLED WITH A VISUAL INSPECTION; A TIGHTNESS TEST OF THE BALLOON IS ALSO PERFORMED ON EVERY UNIT; THE INTEGRITY OF THE MICRO-CATHETERS ARE 100% CONTROLLED; THE HYDROPHILIC COATING APPEARANCE AND CLEANLINESS ARE 100% CONTROLLED; A SLIDING TEST IS ALSO PERFORMED ON A SAMPLE OF MICROCATHETERS; THE RINGS ARE 100% CONTROLLED. THERE IS A NO OTHER COMPLAINT REGISTERED ON THIS LOT NUMBER TO DATE. THE INCIDENT DESCRIPTION MENTIONED THAT THERE WAS REFLUX OF EMBOLIC AGENT DURING THE INJECTION AND THAT THE ECLIPSE2L THEN REVEALED BEING ENTRAPPED INTO THIS ("ONYX REFLUX WAS NOTED TO EXTEND TO THE TIP OF THE BALLOON (ALONG THE DISTAL 7MM TIP OF THE ECLIPSE CATHETER). THE CATHETER APPEARED TO BE STUCK AS THE CATHETER WAS BEING REMOVED."). BY CORRELATING THIS INFORMATION WITH OUR POST-MARKETING SURVEILLANCE PROGRAM, SUCH BLOCKAGES ARE GENERALLY CAUSED BY THE EMBOLIC AGENT REFLUX BEYOND THE CATHETER'S DISTAL EXTREMITY. THE DAMAGES MENTIONED ("THE CATHETER APPEARED TO BE STRETCHING AS TRACTION CONTINUED ON THE CATHETER. AFTER ABOUT 15 MINUTES OF TRACTION BEING APPLIED TO THE CATHETER, THE CATHETER BROKE AROUND THE 15CM FROM THE DISTAL TIP") COULD ASSUREDLY BE LINKED WITH THE REMOVAL ATTEMPTS AFTER THE DEVICE WAS ENTRAPPED WITHIN THE EMBOLIC AGENT. SO, THIS INCIDENT TYPE IS UNLIKELY LINKED TO THE DEVICE ITSELF SINCE THERE IS NOT A TECHNICAL CHARACTERISTIC THAT COULD EXPLAIN THE TRAPPING. IN CONCLUSION, THE INCIDENT REPORTED (EMBOLIC AGENT TRAPPING) CANNOT BE LINKED TO A POTENTIAL TECHNICAL FAILURE OF THE BALLOON CATHETER ECLIPSE2L. MANUFACTURING RECORDS COMPLIED TO SPECIFICATIONS AND PRODUCT WAS NOT AVAILABLE FOR INSPECTION. THE TREND OF THIS FAILURE MODE WILL CONTINUE TO BE MONITORED AS PART OF OUR POST-MARKETING SURVEILLANCE PROGRAM. REVIEW OF THE LOT HISTORY RECORDS DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINTS AGAINST LOT NUMBER F210200306 HAS BEEN MADE FOR THE SAME ISSUE. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OF THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
IT WAS REPORTED THAT: "AFTER FOLLOWING THE IFU TO CORRECTLY PREP THE ECLIPSE BALLOON, THE PHYSICIAN SUCCESSFULLY TRACKED AN ECLIPSE DL BALLOON (USING A HYBRID 12/14) TO THE MAIN FEEDING PEDICLE, ARISING FROM THE ANTERIOR TEMPORAL ARTERY ON THE PATIENTS LEFT SIDE. THE BALLOON WAS INFLATED USING A MIXTURE OF 70/30 CONTRAST TO SALINE AND ONYX 18 WAS THE INJECTED THROUGH THE ECLIPSE. A SMALL AMOUNT OF REFLUX WAS NOTICED, EXTENDING ABOUT 50% OF THE WAY BACK FROM THE TIP OF THE BALLOON AND AFTER A BRIEF PAUSE, THE INJECTION WAS CONTINUED UNTIL ANOTHER SLIGHT REFLUX OF ONYX WAS NOTICED AGAIN ABOUT 50% OF THE WAY BACK ON THE BALLOON. THE BALLOON WAS INFLATION WAS INCREASED AND THE INJECTION OF ONYX WAS CONTINUED. AFTER WHAT APPEARED TO BE A COMPLETE EMBOLIZATION, THE BALLOON WAS DEFLATED, AND THE PHYSICIAN BEGAN TO REMOVE THE ECLIPSE BALLOON CATHETER. ONYX REFLUX WAS NOTED TO EXTEND TO THE TIP OF THE BALLOON (ALONG THE DISTAL 7MM TIP OF THE ECLIPSE CATHETER) BUT WAS NOT NOTED TO EXTEND DOWN TO THE AREA OF THE BALLOON OR PAST THE BALLOON. THE CATHETER APPEARED TO BE STUCK AS THE CATHETER WAS BEING REMOVED. THE PHYSICIAN PLACED GENTILE TRACTION ON THE CATHETER FOR OVER 10 MINUTES, IN THE HOPES THAT THE CATHETER WOULD RELEASE FROM THE ONYX CAST. THE CATHETER APPEARED TO BE STRETCHING AS TRACTION CONTINUED ON THE CATHETER. AFTER ABOUT 15 MINUTES OF TRACTION BEING APPLIED TO THE CATHETER, THE CATHETER BROKE AROUND THE 15CM FROM THE DISTAL TIP. THE PROXIMAL END OF THE CATHETER WAS SUCCESSFULLY REMOVED BUT THE DISTAL END OF THE CATHETER REMAINED IN THE PATIENT. THE PATIENT WAS TAKEN DIRECTLY TO MRI AND THEN TO THE OR TO ATTEMPT REMOVAL OF THE CATHETER WHILE THE AVM REMOVAL WAS BEING DONE. THE SURGEON HAD PLANNED TO REMOVE THE AVM TOMORROW. AT THIS TIME THE PATIENT IS BEING TRANSPORTED TO THE OR FOR THE PLANNED SURGERY AND NO ADDITIONAL DETAILS ARE AVAILABLE." UPDATE 27JAN2022 - ADDITIONAL INFORMATION RECEIVED FROM ISSUER: "PHYSICIAN (NEUROSURGEON) COULDN'T RETRIEVE THE CATHETER LAST NIGHT BUT THE ANGIO THIS MORNING DIDN'T LOOK THAT BAD. JUST A BIT OF PLATELET AGGREGATION IN THE M1". HE SAID HE JUST STENTED ACROSS THE M1 TO "JAIL" THE CATHETER AND ANY CATHETER REMNANTS IN THE MAIN MCA AND DOMINANT M2 BRANCH. HE WENT ON TO SAY "SHE SHOULD BE FINE". HE SAID HE WAS KEEPING HER HEPARINIZED TODAY AND THEN WILL START PLAVIX TOMORROW" UPDATE 31JAN2022 - ADDITIONAL INFORMATION RECEIVED FROM ISSUER: "THE PHYSICIAN STATED THAT THE PATIENT RE-BLED ON FRIDAY MORNING (TWO DAYS AFTER THE PROCEDURE). THIS BLEED WAS NOT AT THE SITE OF THE AVM RESECTION BUT IT IS AN EPIDURAL BLEED, SPECIFICALLY AT THE SITE OF THE CRANIOTOMY. THE PATIENT HAD TO BE "HEPRANIZED" DUE TO THE STENT'S BEING USED AND THIS HAS INCREASED HER RISK OF BLEEDING. THE LAST UPDATE I RECEIVED IS THAT SHE IS STABLE. I DID FIND OUT THAT HER AVM HAD PREVIOUSLY RUPTURED 2X AND THAT WAS THE REASON FOR THE EMBOLIZATION AND PLANNED RESECTION." UPDATE 13FEB2022 - ADDITIONAL INFORMATION RECEIVED FROM ISSUER: "I SPOKE TO THE LAB MANAGER AT THIS FACILITY ON FRIDAY AND SHE INFORMED ME THAT SHE HEARD THE PATIENT WAS DOING WELL, BUT HAD NOT BEEN RELEASED FROM THE HOSPITAL YET."
IT WAS REPORTED THAT: "AFTER FOLLOWING THE IFU TO CORRECTLY PREP THE ECLIPSE BALLOON, THE PHYSICIAN SUCCESSFULLY TRACKED AN ECLIPSE DL BALLOON (USING A HYBRID 12/14) TO THE MAIN FEEDING PEDICLE, ARISING FROM THE ANTERIOR TEMPORAL ARTERY ON THE PATIENTS LEFT SIDE. THE BALLOON WAS INFLATED USING A MIXTURE OF 70/30 CONTRAST TO SALINE AND ONYX 18 WAS THE INJECTED THROUGH THE ECLIPSE. A SMALL AMOUNT OF REFLUX WAS NOTICED, EXTENDING ABOUT 50% OF THE WAY BACK FROM THE TIP OF THE BALLOON AND AFTER A BRIEF PAUSE, THE INJECTION WAS CONTINUED UNTIL ANOTHER SLIGHT REFLUX OF ONYX WAS NOTICED AGAIN ABOUT 50% OF THE WAY BACK ON THE BALLOON. THE BALLOON WAS INFLATION WAS INCREASED AND THE INJECTION OF ONYX WAS CONTINUED. AFTER WHAT APPEARED TO BE A COMPLETE EMBOLIZATION, THE BALLOON WAS DEFLATED, AND THE PHYSICIAN BEGAN TO REMOVE THE ECLIPSE BALLOON CATHETER. ONYX REFLUX WAS NOTED TO EXTEND TO THE TIP OF THE BALLOON (ALONG THE DISTAL 7MM TIP OF THE ECLIPSE CATHETER) BUT WAS NOT NOTED TO EXTEND DOWN TO THE AREA OF THE BALLOON OR PAST THE BALLOON. THE CATHETER APPEARED TO BE STUCK AS THE CATHETER WAS BEING REMOVED. THE PHYSICIAN PLACED GENTILE TRACTION ON THE CATHETER FOR OVER 10 MINUTES, IN THE HOPES THAT THE CATHETER WOULD RELEASE FROM THE ONYX CAST. THE CATHETER APPEARED TO BE STRETCHING AS TRACTION CONTINUED ON THE CATHETER. AFTER ABOUT 15 MINUTES OF TRACTION BEING APPLIED TO THE CATHETER, THE CATHETER BROKE AROUND THE 15CM FROM THE DISTAL TIP. THE PROXIMAL END OF THE CATHETER WAS SUCCESSFULLY REMOVED BUT THE DISTAL END OF THE CATHETER REMAINED IN THE PATIENT. THE PATIENT WAS TAKEN DIRECTLY TO MRI AND THEN TO THE OR TO ATTEMPT REMOVAL OF THE CATHETER WHILE THE AVM REMOVAL WAS BEING DONE. THE SURGEON HAD PLANNED TO REMOVE THE AVM TOMORROW. AT THIS TIME THE PATIENT IS BEING TRANSPORTED TO THE OR FOR THE PLANNED SURGERY AND NO ADDITIONAL DETAILS ARE AVAILABLE." UPDATE 27JAN2022 - ADDITIONAL INFORMATION RECEIVED FROM ISSUER: "PHYSICIAN (NEUROSURGEON) COULDN'T RETRIEVE THE CATHETER LAST NIGHT BUT THE ANGIO THIS MORNING DIDN'T LOOK THAT BAD. JUST A BIT OF PLATELET AGGREGATION IN THE M1". HE SAID HE JUST STENTED ACROSS THE M1 TO "JAIL" THE CATHETER AND ANY CATHETER REMNANTS IN THE MAIN MCA AND DOMINANT M2 BRANCH. HE WENT ON TO SAY "SHE SHOULD BE FINE". HE SAID HE WAS KEEPING HER HEPARINIZED TODAY AND THEN WILL START PLAVIX TOMORROW" UPDATE 31JAN2022 - ADDITIONAL INFORMATION RECEIVED FROM ISSUER: "THE PHYSICIAN STATED THAT THE PATIENT RE-BLED ON FRIDAY MORNING (TWO DAYS AFTER THE PROCEDURE). THIS BLEED WAS NOT AT THE SITE OF THE AVM RESECTION BUT IT IS AN EPIDURAL BLEED, SPECIFICALLY AT THE SITE OF THE CRANIOTOMY. THE PATIENT HAD TO BE HEPRANIZED DUE TO THE STENT'S BEING USED AND THIS HAS INCREASED HER RISK OF BLEEDING. THE LAST UPDATE I RECEIVED IS THAT SHE IS STABLE. I DID FIND OUT THAT HER AVM HAD PREVIOUSLY RUPTURED 2X AND THAT WAS THE REASON FOR THE EMBOLIZATION AND PLANNED RESECTION." UPDATE 13FEB2022 - ADDITIONAL INFORMATION RECEIVED FROM ISSUER: "I SPOKE TO THE LAB MANAGER AT THIS FACILITY ON FRIDAY AND SHE INFORMED ME THAT SHE HEARD THE PATIENT WAS DOING WELL, BUT HAD NOT BEEN RELEASED FROM THE HOSPITAL YET."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1196867 | ECLIPSE2L BALLOON CATHETER | ECLIPSE2L | MJN | BALT USA | ECL2L6X9 | F210200306 | 00818053022944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| R |