EXOSEAL
Report
- Report Number
- 9616099-2025-01190
- Event Type
- Malfunction
- Date Received
- July 28, 2025
- Date of Event
- June 30, 2025
- Report Date
- September 8, 2025
- Manufacturer
- CORDIS US CORP
- Product Code
- MGB
- UDI-DI
- 10705032058858
- PMA / PMN Number
- P100013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AS REPORTED, THE PLUG OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) WAS FOUND TO NOT BE FULLY RELEASED. THE PLUG AND DEVICE WERE WITHDRAWN TOGETHER. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION FOR TEN MINUTES. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY CONNECTING THE VASCULAR SHEATH INTRODUCER WITH THE EXOSEAL VCD. NO RESISTANCE OR FRICTION WAS EXPERIENCED AS THE EXOSEAL VCD WAS ADVANCED THROUGH THE SHEATH, AND THE SHEATH WAS NOT KINKED OR BENT. THE VASCULAR SHEATH INTRODUCER WAS RETRACTED UNTIL THE HUB ENGAGED WITH THE INDICATOR WIRE COWLING, AND IT LOCKED AGAINST THE HANDLE ASSEMBLY WITH AN AUDIBLE CLICK. PULSATILE FLOW WAS OBSERVED FROM THE BLEED-BACK INDICATOR, AND THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER WERE RETRACTED TOGETHER UNTIL PULSATILE FLOW SIGNIFICANTLY SLOWED OR STOPPED. THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER WERE RETRACTED TOGETHER UNTIL THE INDICATOR WINDOW CHANGED TO A SOLID BLACK COLOR. THE BUTTON WAS PRESSED AND THE USER PAUSED FOR FIFTEEN SECONDS AND THEN THE DEVICE WAS WITHDRAWN. THERE WAS NO ISSUE WITH OR DAMAGE TO THE DEPLOYMENT LEVER; HOWEVER, AFTER DEPRESSING THE BUTTON, THE PLUG REMAINED IN THE DELIVERY ROD. A THROMBECTOMY WAS PERFORMED ALONG WITH "ZENFLOW 2150" AND 460MM BALLOON ANGIOPLASTY USING AN UNKNOWN 460MM BALLOON. THE PROCEDURE USED A RETROGRADE APPROACH. THE USER IS TRAINED TO THE DEVICE. THE EXOSEAL VCD WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE OF THE VASCULAR SHEATH INTRODUCER (30¿45 DEGREES), AND THE VESSEL DIAMETER WAS CONFIRMED TO BE GREATER THAN OR EQUAL TO 5 MM. THERE WAS NO VISIBLE CALCIUM OR PLAQUE AT THE PUNCTURE SITE, NO STENT NEAR THE SITE, NO VESSEL STENOSIS GREATER THAN 50%, AND NO PRIOR CLOSURE WITH A DEVICE OR MANUAL COMPRESSION WITHIN 30 DAYS. ADDITIONALLY, THERE WAS NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE. ONE NON-STERILE EXOSEAL VASCULAR CLOSURE DEVICE 6F INVOLVED IN THE REPORTED COMPLAINT WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE SHOWED THAT THE DEPLOYMENT LEVER WAS RECEIVED DEPRESSED, WHILE THE GUARD WAS LOCKED. THE PLUG WAS NOT RECEIVED FOR THIS EVALUATION AND THE INDICATOR WIRE WAS FOUND RETRACTED. A NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WAS RETURNED INSERTED ON THE RECEIVED UNIT. FINALLY, IT WAS OBSERVED THAT THE INDICATOR WINDOW WAS RECEIVED IN THE BLACK/WHITE AND RED POSITION. DURING THIS VISUAL ANALYSIS NO ADDITIONAL ANOMALIES WERE OBSERVED TO BE REPORTED. A DIMENSIONAL ANALYSIS OF THE DELIVERY SHAFT INNER DIAMETER (ID) WAS CONDUCTED IN THE RECEIVED UNIT. THE RESULT OBTAINED WAS WITHIN SPECIFICATION. THE FUNCTIONAL DEPLOYMENT SIMULATION EVALUATION COULD NOT BE PERFORMED, AS THE DEVICE WAS RECEIVED IN FULLY DEPLOYED CONDITION. A HIGH MAGNIFICATION EVALUATION WAS EXECUTED TO EVALUATE THE INTERNAL MECHANISM. DURING THIS ANALYSIS, NO ABNORMAL CONDITIONS WERE OBSERVED TO BE REPORTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 18417263 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. THE REPORTED EVENT OF ¿VASCULAR CLOSURE DEVICE (VCD) DEPLOYMENT DIFFICULTY PARTIAL DEPLOYMENT¿ WAS NOT OBSERVED THROUGH ANALYSIS OF THE RETURNED DEVICE SINCE THE DEVICE WAS RECEIVED WITH NO PLUG AND FULLY DEPLOYED. DIMENSIONAL ANALYSIS WAS WITHIN SPECIFICATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. UNSPECIFIED PROCEDURAL, HANDLING, AND/OR ANATOMICAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE USER IS INSTRUCTED TO USE THE LEFT HAND TO ANCHOR THE VASCULAR SHEATH INTRODUCER AND THE EXOSEAL VCD IN A STATIONARY POSITION. THE USER IS THEN INSTRUCTED TO PRESS THE PLUG DEPLOYMENT BUTTON TO DEPLOY THE PLUG, ENSURING THE PLUG DEPLOYMENT BUTTON IS FULLY DEPRESSED AND FLUSH AGAINST THE HANDLE ASSEMBLY. THE INDICATOR WIRE WILL AUTOMATICALLY WITHDRAW AND THE PLUG WILL BE DEPLOYED. THE IFU CAUTIONS THAT CARE SHOULD BE TAKEN TO ENSURE NO FURTHER PULLBACK OF THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER OCCURS PRIOR TO, OR DURING, DEPLOYMENT OF THE PLUG. APPROXIMATELY 1-2 SECONDS AFTER DEPRESSING THE DEPLOYMENT BUTTON, THE USER IS INSTRUCTED TO RETRACT THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER AS A UNIT UNTIL THE SYSTEM IS FULLY REMOVED FROM THE PATIENT AND APPLY LIGHT, NON-OCCLUSIVE PRESSURE TO THE WOUND SITE. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE IS NO INDICATION TO SUGGEST THAT THE REPORTED FAILURE COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: B5, D9, G3, G6, H1, H2, H3. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT: 18417263 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. THIS DEVICE HAS BEEN ANALYZED BUT THE FINAL, APPROVED DRAFT OF THE ENGINEERING REPORT AND ITS CONCLUSION 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.
DUE TO SYSTEM LIMITATIONS, SECTION H6 REQUIRED TO INPUT TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS FOR AN INITIAL REPORT. PENDING ADDITIONAL INFORMATION TO COMPLETE INVESTIGATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, THE PLUG OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) WAS FOUND TO NOT BE FULLY RELEASED. THE PLUG AND DEVICE WERE WITHDRAWN TOGETHER. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION FOR 10 MINUTES. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY CONNECTING THE VASCULAR SHEATH INTRODUCER WITH THE EXOSEAL VCD. NO RESISTANCE OR FRICTION WAS EXPERIENCED AS THE EXOSEAL VCD WAS ADVANCED THROUGH THE SHEATH, AND THE SHEATH WAS NOT KINKED OR BENT. THE VASCULAR SHEATH INTRODUCER WAS RETRACTED UNTIL THE HUB ENGAGED WITH THE INDICATOR WIRE COWLING, AND IT LOCKED AGAINST THE HANDLE ASSEMBLY WITH AN AUDIBLE CLICK. PULSATILE FLOW WAS OBSERVED FROM THE BLEED-BACK INDICATOR, AND THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER WERE RETRACTED TOGETHER UNTIL PULSATILE FLOW SIGNIFICANTLY SLOWED OR STOPPED. THE EXOSEAL VCD AND VASCULAR SHEATH INTRODUCER WERE RETRACTED TOGETHER UNTIL THE INDICATOR WINDOW CHANGED TO A SOLID BLACK COLOR. THE BUTTON WAS PRESSED AND THE USER PAUSED FOR 15 SECONDS AND THEN THE DEVICE WAS WITHDRAWN. THERE WAS NO ISSUE WITH OR DAMAGE TO THE DEPLOYMENT LEVER; HOWEVER, AFTER DEPRESSING THE BUTTON, THE PLUG REMAINED IN THE DELIVERY ROD. A THROMBECTOMY WAS PERFORMED ALONG WITH "ZENFLOW 2150" AND 460MM BALLOON ANGIOPLASTY USING AN UNKNOWN 460MM BALLOON. THE PROCEDURE USED A RETROGRADE APPROACH. THE USER IS TRAINED TO THE DEVICE. THE EXOSEAL VCD WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE OF THE VASCULAR SHEATH INTRODUCER (30¿45 DEGREES), AND THE VESSEL DIAMETER WAS CONFIRMED TO BE GREATER THAN OR EQUAL TO 5 MM. THERE WAS NO VISIBLE CALCIUM OR PLAQUE AT THE PUNCTURE SITE, NO STENT NEAR THE SITE, NO VESSEL STENOSIS GREATER THAN 50%, AND NO PRIOR CLOSURE WITH A DEVICE OR MANUAL COMPRESSION WITHIN 30 DAYS. ADDITIONALLY, THERE WAS NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE. THE DEVICE WAS RETURNED FOR ANALYSIS.
AS REPORTED, THE PLUG OF A 6F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) WAS FOUND TO NOT BE FULLY RELEASED. THE PLUG AND DEVICE WERE WITHDRAWN TOGETHER. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION FOR 10 MINUTES. THERE WAS NO REPORTED PATIENT INJURY. THE USER IS TRAINED TO THE DEVICE. A THROMBECTOMY WAS PERFORMED ALONG WITH "ZENFLOW 2150" AND 460MM BALLOON ANGIOPLASTY USING AN UNKNOWN 460MM BALLOON. THE BUTTON WAS PRESSED AND THE USER PAUSED FOR 15 SECONDS AND THEN THE DEVICE WAS WITHDRAWN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 685769 | EXOSEAL | DEVICE, HEMOSTASIS, VASCULAR | MGB | CORDIS US CORP | N/A | 18417263 | 10705032058858 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male | ROTAREX THROMBECTOMY.| TERUMO RADIFOCUS 6 F SHORT SHEATH.| ZENFLOW 2150 AND 460MM BALLOON ANGIOPLASTY. |