VERSACROSS ACCESS SOLUTION
Report
- Report Number
- 2124215-2025-77679
- Event Type
- Injury
- Date Received
- October 29, 2025
- Date of Event
- January 3, 2025
- Report Date
- December 18, 2025
- Manufacturer
- BAYLIS MEDICALE CIE INC
- Product Code
- DXF
- PMA / PMN Number
- K150709
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THE FIELD DATE OF EVENT (B3) WAS UPDATED WITH THE DATE OF THE AOI WAS PUBLISHED, SINCE AOI HAS NO SPECIFIC PROCEDURE DATE. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. THIS WAS NOT AVAILABLE BECAUSE THIS WAS RELATED TO A LITERATURE STUDY. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. ARTICLE CITATION: SINGH, A., GAUTAM GADEY, & LABIB, S. B. (2025). DELAYED TAMPONADE AFTER TRANSSEPTAL PUNCTURE. JACC CASE REPORTS, 30(7), 103379-103379. HTTPS://DOI.ORG/10.1016/J.JACCAS.2025.103379.
THE DEVICE DID NOT RETURNED FOR ANALYSIS. HOWEVER, THE REPORTED ALLEGATION OF THROMBUS IS CONFIRMED THROUGH THE MEDIA PROVIDED. ALL OTHER ALLEGATIONS CANNOT BE CONFIRMED BASED ON THE INFORMATION AVAILABLE. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THE FIELD DATE OF EVENT (B3) WAS UPDATED WITH THE DATE OF THE AOI WAS PUBLISHED, SINCE AOI HAS NO SPECIFIC PROCEDURE DATE. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. THIS WAS NOT AVAILABLE BECAUSE THIS WAS RELATED TO A LITERATURE STUDY. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. ARTICLE CITATION: SINGH, A., GAUTAM GADEY, & LABIB, S. B. (2025). DELAYED TAMPONADE AFTER TRANSSEPTAL PUNCTURE. JACC CASE REPORTS, 30(7), 103379-103379. HTTPS://DOI.ORG/10.1016/J.JACCAS.2025.103379.
IT WAS REPORTED THAT A CARDIAC TAMPONADE OCCURRED. PER LITERATURE REVIEW, A 75-YEAR-OLD MAN WITH SYMPTOMATIC MITRAL REGURGITATION (MR) UNDERWENT TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER). HIS HISTORY INCLUDED LIVER AND KIDNEY TRANSPLANTS, AND ATRIAL FIBRILLATION, NOT ANTICOAGULATED DUE TO HIGH BLEEDING RISK. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED SEVERE ECCENTRIC POSTERIORLY DIRECTED MR AND A LARGE FLAIL ANTERIOR LEAFLET SEGMENT. HEPARIN WAS ADMINISTERED BEFORE TRANSSEPTAL PUNCTURE (TSP). AN 8.5-F VERSACROSS SHEATH WAS PLACED VIA THE RIGHT FEMORAL VEIN. A NRG NEEDLE WAS USED FOR TRANSSPETAL. TEE REVEALED A DIMINUTIVE FOSSA OVALIS (FO). INITIAL TENTING IN THE FOSSA DEMONSTRATED INADEQUATE HEIGHT TO THE MITRAL VALVE, PROMPTING DELIBERATE REPOSITIONING OF THE PUNCTURE POSTERIOR TO THE FOSSA TO GAIN HEIGHT. SUCCESSFUL TSP WAS CONFIRMED WITH IMAGING WITHOUT IMMEDIATE COMPLICATIONS. THREE MITRACLIPS WERE ULTIMATELY DEPLOYED REDUCING MR FROM SEVERE TO MILD WITH NORMALIZATION OF PULMONARY VEIN FLOW PATTERN. TRACE PERICARDIAL EFFUSION FIRST APPEARED AFTER THE SECOND MITRACLIP DEPLOYMENT (111 MINUTES AFTER TSP), WHICH REMAINED UNCHANGED IN SIZE (2-4 MM) THROUGHOUT DEPLOYMENT OF A THIRD CLIP. THE EFFUSION ABRUPTLY INCREASED 20 MINUTES LATER AS SOON AS THE GUIDE WAS PULLED BACK INTO THE RIGHT ATRIUM, CAUSING CHAMBER COMPRESSION AND HYPOTENSION. PERICARDIOCENTESIS WAS INEFFECTIVE DUE TO CLOTTED BLOOD, PROMPTING EMERGENT SURGICAL PERICARDIAL WINDOW IN THE CATHETERIZATION LABORATORY WITH FULL RESOLUTION OF THE EFFUSION. A SEPTAL OCCLUDER WAS CONSIDERED BUT DEFERRED DUE TO BLEEDING CESSATION AND UNCERTAIN EFFICACY, ALTHOUGH THEORETICALLY APPEALING. THE PATIENT WAS DISCHARGED IN STABLE CONDITION 6 DAYS AFTER THE PROCEDURE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (LITERATURE REVIEW). ARTICLE CITATION: SINGH, A., GAUTAM GADEY, & LABIB, S. B. (2025). DELAYED TAMPONADE AFTER TRANSSEPTAL PUNCTURE. JACC CASE REPORTS, 30(7), 103379-103379. HTTPS://DOI.ORG/10.1016/J.JACCAS.2025.103379.
IT WAS REPORTED THAT A CARDIAC TAMPONADE OCCURRED. PER LITERATURE REVIEW, A 75-YEAR-OLD MAN WITH SYMPTOMATIC MITRAL REGURGITATION (MR) UNDERWENT TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER). HIS HISTORY INCLUDED LIVER AND KIDNEY TRANSPLANTS, AND ATRIAL FIBRILLATION, NOT ANTICOAGULATED DUE TO HIGH BLEEDING RISK. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED SEVERE ECCENTRIC POSTERIORLY DIRECTED MR AND A LARGE FLAIL ANTERIOR LEAFLET SEGMENT. HEPARIN WAS ADMINISTERED BEFORE TRANSSEPTAL PUNCTURE (TSP). AN 8.5-F VERSACROSS SHEATH WAS PLACED VIA THE RIGHT FEMORAL VEIN. A NRG NEEDLE WAS USED FOR TRANSSPETAL. TEE REVEALED A DIMINUTIVE FOSSA OVALIS (FO). INITIAL TENTING IN THE FOSSA DEMONSTRATED INADEQUATE HEIGHT TO THE MITRAL VALVE, PROMPTING DELIBERATE REPOSITIONING OF THE PUNCTURE POSTERIOR TO THE FOSSA TO GAIN HEIGHT. SUCCESSFUL TSP WAS CONFIRMED WITH IMAGING WITHOUT IMMEDIATE COMPLICATIONS. THREE MITRACLIPS WERE ULTIMATELY DEPLOYED REDUCING MR FROM SEVERE TO MILD WITH NORMALIZATION OF PULMONARY VEIN FLOW PATTERN. TRACE PERICARDIAL EFFUSION FIRST APPEARED AFTER THE SECOND MITRACLIP DEPLOYMENT (111 MINUTES AFTER TSP), WHICH REMAINED UNCHANGED IN SIZE (2-4 MM) THROUGHOUT DEPLOYMENT OF A THIRD CLIP. THE EFFUSION ABRUPTLY INCREASED 20 MINUTES LATER AS SOON AS THE GUIDE WAS PULLED BACK INTO THE RIGHT ATRIUM, CAUSING CHAMBER COMPRESSION AND HYPOTENSION. PERICARDIOCENTESIS WAS INEFFECTIVE DUE TO CLOTTED BLOOD, PROMPTING EMERGENT SURGICAL PERICARDIAL WINDOW IN THE CATHETERIZATION LABORATORY WITH FULL RESOLUTION OF THE EFFUSION. A SEPTAL OCCLUDER WAS CONSIDERED BUT DEFERRED DUE TO BLEEDING CESSATION AND UNCERTAIN EFFICACY, ALTHOUGH THEORETICALLY APPEALING. THE PATIENT WAS DISCHARGED IN STABLE CONDITION 6 DAYS AFTER THE PROCEDURE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (LITERATURE REVIEW). ARTICLE CITATION: SINGH, A., GAUTAM GADEY, & LABIB, S. B. (2025). DELAYED TAMPONADE AFTER TRANSSEPTAL PUNCTURE. JACC CASE REPORTS, 30(7), 103379-103379. HTTPS://DOI.ORG/10.1016/J.JACCAS.2025.103379.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2719107 | VERSACROSS ACCESS SOLUTION | CATHETER, SEPTOSTOMY | DXF | BAYLIS MEDICALE CIE INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Required Intervention| H |