ISLEEVE 14F
Report
- Report Number
- 2124215-2025-23573
- Event Type
- Malfunction
- Date Received
- April 16, 2025
- Date of Event
- April 3, 2025
- Report Date
- October 1, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED WITH AN UPDATE TO SECTIONS: H6 COMPONENT CODES. H6 EVALUATION METHOD CODES. H6 EVALUATION RESULT CODES. H6 EVALUATION CONCLUSION CODES. MEDIA ANALYSIS: ONE (1) FLUOROSCOPIC STILL IMAGE AND ONE (1) FLUOROSCOPIC VIDEO WERE PROVIDED TO ASSIST IN THE INVESTIGATION AND WERE REVIEWED BY A BSC QUALITY TECHNICIAN. THE FLUOROSCOPIC MEDIA SHOWED A FRAGMENT SIMILAR IN SHAPE TO THE TIP OF A 14F ISLEEVE INTRODUCER SHEATH IN THE PATIENT VASCULATURE. PROCEDURAL IMAGINED CONFIRMED THE REPORTED EVENT.
DEVICE EVALUATED BY MFR.: THE 14F ISLEEVE INTRODUCER SHEATH WAS RETURNED AND ANALYZED BY A BSC QUALITY TECHNICIAN. THE RETURNED DEVICE CONSISTED OF AN 14F ISLEEVE INTRODUCER SHEATH WITH THE DILATOR COMPLETELY INSIDE THE SHEATH UP TO THE HUB WITH THE TIP OF THE DILATOR PROTRUDING OUT OF THE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH. MICROSCOPIC ANALYSIS IDENTIFIED A PORTION OF THE TIP WAS DETACHED AND NOT RETURNED. ONE (1) FLUOROSCOPIC STILL IMAGE AND ONE (1) FLUOROSCOPIC VIDEO WERE PROVIDED TO ASSIST IN THE INVESTIGATION AND WERE REVIEWED BY A BSC QUALITY TECHNICIAN. THE FLUOROSCOPIC MEDIA SHOWED A FRAGMENT SIMILAR IN SHAPE TO THE TIP OF A 14F ISLEEVE INTRODUCER SHEATH IN THE PATIENT VASCULATURE. DEVICE ANALYSIS AND PROCEDURAL IMAGINING CONFIRMED THE REPORTED EVENT.
IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, FEMORAL ACCESS WAS OBTAINED VIA THE MILDLY TORTUOUS RIGHT FEMORAL ARTERY. THE RIGHT FEMORAL ARTERY HAD A DIAMETER OF 7.4MM. A 14F ISLEEVE INTRODUCER SHEATH WAS PLACED IN THE FEMORAL ARTERY. AN ACURATE PRIME DELIVERY SYSTEM (DS) WAS ADVANCED WITHOUT RESISTANCE. THE 25MM ACURATE PRIME VALVE WAS SUCCESSFULLY IMPLANTED. FEMORAL ARTERY SUTURES WERE PLACED AND THE 14F ISLEEVE INTRODUCER SHEATH WAS REMOVED. UPON REMOVAL OF THE 14F ISLEEVE INTRODUCER SHEATH FROM THE PATIENT IT WAS DISCOVERED A PORTION OF THE RADIOPAQUE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH HAD DETACHED. THE DETACHED TIP WAS LOCATED IN THE FEMORAL ARTERY CREATING A NON-FLOW-LIMITING STENOSIS. THE CAUSE OF THE TIP DETACHMENT WAS POSSIBLY ATTRIBUTED TO THE 14 ISLEEVE INTRODUCER SHEATH BEING TRAPPED IN THE ARTERY SUTURES OR AN INTERACTION WITH THE ACURATE PRIME DELIVERY SYSTEM; HOWEVER THE CAUSE WAS UNABLE TO BE CONFIRMED. A VASCULAR SURGEON WAS CONSULTED AND AS THE DETACHED TIP WAS NOT LIMITING BLOOD FLOW, THE DETACHED TIP WAS LEFT INSIDE OF THE PATIENT WITH NO INTERVENTIONS PLANNED TO REMOVE THE DETACHED TIP. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, FEMORAL ACCESS WAS OBTAINED VIA THE MILDLY TORTUOUS RIGHT FEMORAL ARTERY. THE RIGHT FEMORAL ARTERY HAD A DIAMETER OF 7.4MM. A 14F ISLEEVE INTRODUCER SHEATH WAS PLACED IN THE FEMORAL ARTERY. AN ACURATE PRIME DELIVERY SYSTEM (DS) WAS ADVANCED WITHOUT RESISTANCE. THE 25MM ACURATE PRIME VALVE WAS SUCCESSFULLY IMPLANTED. FEMORAL ARTERY SUTURES WERE PLACED AND THE 14F ISLEEVE INTRODUCER SHEATH WAS REMOVED. UPON REMOVAL OF THE 14F ISLEEVE INTRODUCER SHEATH FROM THE PATIENT IT WAS DISCOVERED A PORTION OF THE RADIOPAQUE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH HAD DETACHED. THE DETACHED TIP WAS LOCATED IN THE FEMORAL ARTERY CREATING A NON-FLOW-LIMITING STENOSIS. THE CAUSE OF THE TIP DETACHMENT WAS UNABLE TO BE CONFIRMED, HOWEVER WAS THOUGHT TO BE POSSIBLY ATTRIBUTED TO THE 14 ISLEEVE INTRODUCER SHEATH BEING TRAPPED IN THE ARTERY SUTURES OR AN INTERACTION WITH THE ACURATE PRIME DELIVERY SYSTEM. NO RESISTANCE WAS FELT DURING ACURATE PRIME DELIVERY SYSTEM WITHDRAWAL. A VASCULAR SURGEON WAS CONSULTED AND AS THE DETACHED TIP WAS NOT LIMITING BLOOD FLOW, THE DETACHED TIP WAS LEFT INSIDE OF THE PATIENT WITH NO INTERVENTIONS PLANNED TO REMOVE THE DETACHED TIP. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, FEMORAL ACCESS WAS OBTAINED VIA THE MILDLY TORTUOUS RIGHT FEMORAL ARTERY. THE RIGHT FEMORAL ARTERY HAD A DIAMETER OF 7.4MM. A 14F ISLEEVE INTRODUCER SHEATH WAS PLACED IN THE FEMORAL ARTERY. AN ACURATE PRIME DELIVERY SYSTEM (DS) WAS ADVANCED WITHOUT RESISTANCE. THE 25MM ACURATE PRIME VALVE WAS SUCCESSFULLY IMPLANTED. FEMORAL ARTERY SUTURES WERE PLACED AND THE 14F ISLEEVE INTRODUCER SHEATH WAS REMOVED. UPON REMOVAL OF THE 14F ISLEEVE INTRODUCER SHEATH FROM THE PATIENT IT WAS DISCOVERED A PORTION OF THE RADIOPAQUE TIP OF THE 14F ISLEEVE INTRODUCER SHEATH HAD DETACHED. THE DETACHED TIP WAS LOCATED IN THE FEMORAL ARTERY CREATING A NON-FLOW-LIMITING STENOSIS. THE CAUSE OF THE TIP DETACHMENT WAS UNABLE TO BE CONFIRMED, HOWEVER WAS THOUGHT TO BE POSSIBLY ATTRIBUTED TO THE 14 ISLEEVE INTRODUCER SHEATH BEING TRAPPED IN THE ARTERY SUTURES OR AN INTERACTION WITH THE ACURATE PRIME DELIVERY SYSTEM. NO RESISTANCE WAS FELT DURING ACURATE PRIME DELIVERY SYSTEM WITHDRAWAL. A VASCULAR SURGEON WAS CONSULTED AND AS THE DETACHED TIP WAS NOT LIMITING BLOOD FLOW, THE DETACHED TIP WAS LEFT INSIDE OF THE PATIENT WITH NO INTERVENTIONS PLANNED TO REMOVE THE DETACHED TIP. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 109912 | ISLEEVE 14F | INTRODUCER, CATHETER | DYB | BOSTON SCIENTIFIC CORPORATION | 10445 | 0035692936 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female |