EDWARDS ESHEATH+ INTRODUCER SET
Report
- Report Number
- 2015691-2022-05453
- Event Type
- Malfunction
- Date Received
- April 28, 2022
- Date of Event
- April 6, 2022
- Report Date
- December 9, 2022
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYB
- UDI-DI
- 00690103215465
- PMA / PMN Number
- K200258
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS ONGOING. DEVICE NOT RETURNED.
SECTION D UPDATE THE PREVIOUSLY REPORTED DEVICE INFORMATION (LOT NUMBER 64183829, UDI (B)(4), MANUFACTURE DATE JAN 13, 2022, EXPIRATION DATE JAN 13, 2024, PMA# K200258 IS APPLICABLE TO THIS EVENT AS THE LOT NUMBER IS UNKNOWN. IN ADDITION, THE FOLLOWING DEVICE INFORMATION IS APPLICABLE DEVICE INFORMATION (LOT NUMBER 64193266, UDI (B)(4), MANUFACTURE DATE JAN 15, 2022, EXPIRATION DATE JAN 15, 2024, PMA# K200258 IS APPLICABLE TO THIS EVENT AS THE LOT NUMBER IS UNKNOWN. IN ADDITION, THE FOLLOWING DEVICE INFORMATION (LOT NUMBER 6464199201, UDI (B)(4). MANUFACTURE DATE JAN 09, 2022, EXPIRATION DATE JAN 09, 2024, PMA# K200258 IS APPLICABLE TO THIS EVENT AS THE LOT NUMBER IS UNKNOWN. IN ADDITION, THE FOLLOWING DEVICE. A DEVICE HISTORY RECORD REVIEW (DHR) WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING NONCONFORMANCE THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT EVENT. A COMPLAINT HISTORY REVIEW ON CONFIRMED DEVICE COMPLAINTS (RETURNED AND NO PRODUCT RETURNED) FROM MAY 2021 TO APRIL 2022 FOR THE ESHEATH+ INTRODUCER SET (ALL MODELS AND SIZES) WAS PERFORMED. PRIOR CLOSED COMPLAINTS WERE REVIEWED FOR SIMILAR EVENTS AND ROOT CAUSE IDENTIFICATION. OF THE ROOT CAUSES IDENTIFIED, THE FOLLOWING ARE POTENTIALLY APPLICABLE TO THE COMPLAINT EVENT: PATIENT FACTORS: CALCIFICATION, TORTUOSITY. A REVIEW OF THE LOT HISTORY REVEALED NO COMPLAINTS RELATED TO THE EVENTS FAILURE SHEATH DISTAL TIP TORN, SHEATH INSERTION AND SUTURING DIFFICULTY INTRODUCING SHEATH AND SHEATH INSERTION AND SUTURING INABILITY TO INTRODUCE SHEATH.
UPDATE TO B4, G3, G6, H2 H6 TO REFLECT NO DEVICE RETURN EVALUATION. THE SHEATH WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. A REVIEW OF IMAGERY PROVIDED SHOWED THE FOLLOWING: TORTUOSITY AND CALCIFICATION PRESENT IN PATIENT'S ACCESS VESSEL. THE DISTAL TIP OF SHEATH WAS SLIGHTLY OPENED ALONG THE AXIAL SCORE LINE AND DAMAGED; THE SHEATH DISTAL TIP IS DESIGNED TO OPEN DURING DELIVERY SYSTEM ADVANCEMENT. DUE TO THE UNAVAILABILITY OF THE DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS. THEREFORE, A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED DURING THE EVALUATION. A DEVICE HISTORY REVIEW (DHR) AND LOT HISTORY REVIEW WERE NOT PERFORMED AS THE DEVICE LOT NUMBER WAS NOT PROVIDED. A COMPLAINT HISTORY REVIEW ON CONFIRMED DEVICE COMPLAINTS (RETURNED AND NO PRODUCT RETURNED) FROM MAY 2021 TO APRIL 2022 FOR THE ESHEATH+ INTRODUCER SET (ALL MODELS AND SIZES) WAS PERFORMED. PRIOR CLOSED COMPLAINTS WERE REVIEWED FOR SIMILAR EVENTS AND ROOT CAUSE IDENTIFICATION. OF THE ROOT CAUSES IDENTIFIED, THE FOLLOWING ARE POTENTIALLY APPLICABLE TO THE COMPLAINT EVENT: PATIENT FACTORS: CALCIFICATION, TORTUOSITY. THE FOLLOWING INSTRUCTIONS WERE REVIEWED ESHEATH+ INTRODUCER SET IFU, DEVICE PREPARATION MANUAL, PROCEDURAL TRAINING MANUAL. EDWARDS HAS PROVIDED THE GUIDELINES OR INSTRUCTIONS TO PHYSICIANS IN THE IFU AND DEVICE PREPARATION AND PROCEDURAL TRAINING MANUALS. NO IFU TRAINING DEFICIENCIES WERE IDENTIFIED. DURING MANUFACTURING, THE SHEATH SHAFT COMPONENTS WERE 100% VISUALLY INSPECTED FOR ANY DEFECTS. DURING THE MANUFACTURING PROCESS THE ESHEATH FINAL ASSEMBLIES WERE 100% VISUALLY INSPECTED BY BOTH MANUFACTURING AND QUALITY. THE INSPECTIONS AND TESTS DESCRIBED ABOVE SUPPORT THAT IT IS UNLIKELY A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION WAS PERFORMED, AND THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. THE COMPLAINTS FOR ''SHEATH INSERTION AND SUTURING INABILITY TO INTRODUCE SHEATH'' AND ''GENERAL RISK FAILURE SHEATH DISTAL TIP TORN'' WERE CONFIRMED. AS THE DEVICE WAS NOT RETURNED, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS. THEREFORE, THE PRESENCE OF A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. AS THE LOT WAS NOT PROVIDED, REVIEWS OF THE DHR AND LOT HISTORY WERE UNABLE TO BE PERFORMED. A REVIEW OF THE IFU AND TRAINING MANUALS REVEALED NO DEFICIENCIES. FURTHERMORE, NO ABNORMALITIES WERE OBSERVED DURING DEVICE UNPACKING OR PREPARATION. AS REPORTED, ''IT WAS NOTED THAT THE SHEATH BECAME DAMAGED ON CALCIUM TWICE. NEW SHEATHS WERE REQUESTED. THE DILATOR AND SHEATH INSERTION WERE ATTEMPTED MULTIPLE TIMES, AND SHEATH TIP WAS DAMAGED FROM CALCIUM, SHOCKWAVE WAS PREFORMED, SHEATH STILL WOULD NOT TRACK''. PER THE IFU/TRAINING MANUAL, ''ACCESS CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF THE SHEATH SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION, SEVERE TORTUOSITY OR VESSEL DIAMETERS LESS THAN THE MINIMUM RECOMMENDED SHOULD BE CAREFULLY ASSESSED PRIOR TO THE PROCEDURE''. PER THE TRAINING MANUAL, ''PUSH FORCE CAN VARY DUE TO ANGLE OF INSERTION, VESSEL DIAMETER, TORTUOSITY AND DEGREE OF CALCIFICATION''. RETURNED PATIENT IMAGERY SHOWED TORTUOUS BENDS AND CALCIFICATION IN THE PATIENT'S ACCESS VESSEL. PATIENT FACTORS SUCH AS CALCIFICATION CAN ACT AS AN OBSTACLE FOR THE SHEATH TO FULLY ADVANCE. THE CALCIUM CAN ALSO REDUCE THE VESSEL LUMEN DIAMETER AND ACT AS A PHYSICAL BARRIER, CONSTRAINING THE SHEATH AND LEADING TO DIFFICULTY INTRODUCING THE SHEATH AS WELL AS DIRECT DAMAGE TO THE SHEATH DISTAL TIP. ADDITIONALLY, VESSEL TORTUOSITY CAN SUBJECT THE SHEATH TO SUBOPTIMAL ANGLES THAT CAN INCREASE CONTACT BETWEEN THE SHEATH AND THE PATIENT'S ACCESS VESSEL LEADING TO DIFFICULTY DURING SHEATH INSERTION. IT IS ALSO POSSIBLE THAT THE SHEATH WAS EXCESSIVELY MANIPULATION IN AN ATTEMPT TO OVERCOME THE EXPERIENCED DIFFICULTY, WHICH MAY HAVE FURTHER LED TO THE DISTAL TIP DAMAGE. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (TORTUOSITY, CALCIFICATION) AND PROCEDURAL FACTORS (EXCESSIVE MANIPULATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. A CORRECTIVE/PREVENTATIVE ACTION (CAPA) WAS PREVIOUSLY INITIATED TO PURSUE POTENTIAL PROCESS IMPROVEMENT ACTIVITIES. A PRODUCT RISK ASSESSMENT WAS PREVIOUSLY INITIATED PER MANAGEMENT DISCRETION TO INVESTIGATE THE CAUSE AND ASSESS THE RISK ASSOCIATED WITH SHEATH TIP EXPANSION. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.
THE PREVIOUSLY REPORTED DEVICE INFORMATION (LOT NUMBER 64183829, UDI (B)(4) 240113(11)2201132164183829, MANUFACTURE DATE JAN 13, 2022, EXPIRATION DATE JAN 13, 2024, PMA# K200258 ARE NO LONGER APPLICABLE TO THIS EVENT AS THE LOT NUMBER IS UNKNOWN.
AS REPORTED, DURING PROCEDURE WITH A 23MM ULTRA SAPIEN IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH, THE SHEATH TIP WAS DAMAGED ON CALCIUM. IT WAS SUSPECTED THAT THE SHEATH TORE ON THE TIP IN A JAGGED FASHION WHEN IT WOULD NOT ADVANCE INTO THE PATIENT. A SECOND ESHEATH WAS REQUESTED. A RIGHT ILIAC INJURY WAS CAUSED BY A NON-EDWARDS CLOSURE DEVICE AND A CUTDOWN WAS PERFORMED TO REPAIR THE TRANSECTED ILIAC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58224 | EDWARDS ESHEATH+ INTRODUCER SET | INTRODUCER, CATHETER | DYB | EDWARDS LIFESCIENCES | 914ESPA | 64183829 | 00690103215465 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |