2.4FR NITINOL TIPLESS BASKET
Report
- Report Number
- 1018233-2023-04423
- Event Type
- Malfunction
- Date Received
- June 19, 2023
- Date of Event
- May 29, 2022
- Report Date
- August 3, 2023
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- FFL
- UDI-DI
- 00801741111495
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "BASKET GEOMETRY". IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "INDICATIONS FOR USE: THIS DEVICE IS INTENDED FOR USE IN ENDOSCOPIC REMOVAL OF URETERAL AND RENAL STONES. CONTRAINDICATIONS: NONE KNOWN. WARNINGS: ¿ SOME OBJECTS MAY BE TOO LARGE TO BE REMOVED ENDOSCOPICALLY USING A RETRIEVAL DEVICE. THE USE OF FLUOROSCOPY AND/OR X-RAY TO DETERMINE THE SIZE OF THE OBJECT IS RECOMMENDED. DO NOT USE THE BARD® SKYLITETM TIPLESS NITINOL STONE BASKET IF THE OBJECT IS TOO LARGE TO BE REMOVED ENDOSCOPICALLY, AS IT MAY RESULT IN PATIENT INJURY AND PAIN. ¿ THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR MAY LEAD TO INJURY, ILLNESS OR DEATH OF A PATIENT. ¿ DO NOT ATTEMPT TO REPAIR, REASSEMBLE, OR ALTER THE DEVICE IN ANY WAY. ¿ AFTER USE, THIS PRODUCT WILL BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICES AND WITH APPLICABLE LAWS AND REGULATIONS. FOLLOW YOUR INSTITUTIONAL GUIDELINES. CAUTION: OBJECTS THAT ARE TOO LARGE TO BE REMOVED THROUGH THE SCOPE CHANNEL WILL REQUIRE THE SCOPE AND BASKET TO BE REMOVED SIMULTANEOUSLY FROM THE URINARY TRACT. IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE, STOP AND DETERMINE THE SOURCE OF RESISTANCE, AS CONTINUED RESISTANCE MAY DAMAGE THE DEVICE AND COULD RESULT IN PATIENT INJURY. TAKE ACTION TO ALLEVIATE THE RESISTANCE. PRECAUTIONS: BEFORE USING, INSPECT FOR ANY BREACH OF PACKAGING TO ENSURE STERILITY OF PRODUCT. DO NOT USE IF BREACH IN STERILE BARRIER IS OBVIOUS OR SUSPECTED. DO NOT ALLOW THE DEVICE TO COME IN CONTACT WITH ANY ELECTRIFIED INSTRUMENTS OR LASER. KINKS IN THE SHEATH WILL HINDER THE MECHANICAL OPERATION OF THE BASKET, MAY AFFECT INSERTION OR WITHDRAWAL OF THE BASKET AND HAS THE POTENTIAL TO DAMAGE THE ENDOSCOPE¿S INSTRUMENT CHANNEL. DO NOT ALLOW THE DEVICE TO BE DIRECTLY FIRED UPON BY ANY LITHOTRIPSY DEVICES. TO DO SO MAY RESULT IN DAMAGE TO THE DEVICE AND COULD RESULT IN PATIENT INJURY. CAPTURE AND REMOVAL 1. UNDER DIRECT VISION OR FLUOROSCOPIC GUIDANCE, SLOWLY ADVANCE THE BASKET TIP PAST THE OBJECT. 2. OPEN THE BASKET BY PUSHING THE THUMB SLIDE FORWARD. (REFER TO FIGURE B). 3. PULL THE BASKET BACKWARD TOWARD THE OBJECT WHILE SLOWLY ROTATING THE BASKET AS NECESSARY. 4. ONCE THE OBJECT HAS BEEN CAPTURED, PARTIALLY CLOSE THE BASKET TO SECURE THE OBJECT FOR REMOVAL BY CAREFULLY PULLING THE THUMB SLIDE BACK. (REFER TO FIGURE B). 5. SLOWLY REMOVE THE BASKET AND STONE FROM THE URINARY TRACT. 6. IF THE OBJECT IS TOO LARGE, YOU MAY NEED TO SIMULTANEOUSLY WITHDRAW THE BASKET AND THE URETEROSCOPE FROM THE URINARY SYSTEM. DIRECTIONS FOR DISASSEMBLY IF HANDLE DISASSEMBLY IS DESIRED OR REQUIRED: 1. SQUEEZE BOTTOM HANDLE HALF AT INDICATED POINTS AND PULL DOWN TO REMOVE HANDLE BOTTOM. 2. LOOSEN THUMBSCREW UNTIL BASKET DRIVE WIRE MOVES FREELY. 3. SLIDE SHEATH AND HANDLE ASSEMBLY OVER AND AWAY FROM DRIVE WIRE." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED THAT IN AN ONLINE SURVEY A PHYSICIAN STATED NO WHEN THEY WERE ASKED IF THEY WERE ABLE TO SUCCESSFULLY REMOVE THE RENAL/URETERAL STONE. PHYSICIAN STATED THEY WERE NOT ABLE TO SUCCESSFULLY REMOVE THE RENAL/URETERAL STONE BECAUSE IMPACTED STONE THAT DID NOT COMPLETELY COME OUT IN RELATION TO 042400 ¿ SKYLITE TM 2.4 FR. NITINOL TIPLESS BASKET, 120CM X 12MM.
IT WAS REPORTED THAT IN AN ONLINE SURVEY A PHYSICIAN STATED NO WHEN THEY WERE ASKED IF THEY WERE ABLE TO SUCCESSFULLY REMOVE THE RENAL/URETERAL STONE. PHYSICIAN STATED THEY WERE NOT ABLE TO SUCCESSFULLY REMOVE THE RENAL/URETERAL STONE BECAUSE IMPACTED STONE THAT DID NOT COMPLETELY COME OUT IN RELATION TO 042400 ¿ SKYLITE TM 2.4 FR. NITINOL TIPLESS BASKET, 120CM X 12MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837715 | 2.4FR NITINOL TIPLESS BASKET | STONE BASKET | FFL | C.R. BARD, INC. (COVINGTON) -1018233 | 042400 | UNK | 00801741111495 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |