ANGIODYNAMICS
Report
- Report Number
- 1317056-2024-00037
- Event Type
- Injury
- Date Received
- February 27, 2024
- Date of Event
- December 18, 2023
- Report Date
- February 28, 2024
- Manufacturer
- ANGIODYNAMICS, INC
- Product Code
- DRE
- PMA / PMN Number
- K132713
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF GUIDEWIRE DETACHED AND WAS RETAINED IN THE PATIENT CANNOT BE CONFIRMED SINCE NO COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION. WITHOUT RECEIVING PRODUCT FOR EVALUATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. THE GUIDEWIRE DEVICE IS SUPPLIED TO ANGIODYNAMICS BY THE SUPPLIER/MANUFACTURER HERAEUS MEDICAL. (B)(6) WAS SENT TO HERAEUS FOR AWARENESS OF THIS COMPLAINT EVENT AND DHR REVIEW OF THE REPORTED LOT NUMBER. (B)(6) RESPONSE STATED THAT NO DEVIATIONS OR NONCONFORMANCES RELATED TO THE EVENT DESCRIPTION WERE IDENTIFIED IN THE RECORD REVIEW. THERE IS NO EVIDENCE TO CONFIRM THE ISSUE IS DUE TO THE MANUFACTURING PROCESS. THIS EVENT IS CONSIDERED A NON-MANUFACTURING-RELATED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS; I.E. NO NCR ASSOCIATED WITH REPORTED FAILURE MODE. LABELING REVIEW: DIRECTION FOR USE (ITEM NUMBER (B)(4) IS PROVIDED WITH THIS MINI-STICK DEVICE. THE FAILURE MODE OF DEVICE FRACTURE AND EMBOLIZATION IS CAUTIONED AS POTENTIAL ADVERSE EVENT. NO SAMPLE WAS RETURNED FOR EVALUATION SO IT CANNOT BE DETERMINED IF DEVICE WAS USED IN A MANNER INCONSISTENT WITH ITS LABELING. ADVERSE EVENTS GUIDEWIRE SHEARING, FRACTURE OR EMBOLIZATION OPERATIONAL INSTRUCTIONS 1. PRIOR TO INSERTION, FLUSH ALL COMPONENTS WITH SALINE OR HEPARINIZED/SALINE. 2. GAIN PERCUTANEOUS ACCESS WITH THE 21 G (0.9 MM) VASCULAR INTRODUCER NEEDLE. 3. ADVANCE THE 0.018 INCH (0.46 MM) GUIDEWIRE THROUGH THE NEEDLE. CAUTION: THE GUIDEWIRE SHOULD NOT BE WITHDRAWN THROUGH THE INTRODUCER NEEDLE. IF THE GUIDEWIRE MUST BE WITHDRAWN WHILE STILL INSIDE THE NEEDLE, SIMULTANEOUSLY REMOVE BOTH THE NEEDLE AND THE WIRE AS A UNIT TO PREVENT THE NEEDLE FROM DAMAGING THE GUIDEWIRE. 4. WITHDRAW THE INTRODUCER NEEDLE, LEAVING THE 0.018 INCH (0.46 MM) GUIDEWIRE IN PLACE. 5. ADVANCE THE COAXIAL ASSEMBLY OVER THE 0.018 INCH (0.46 MM) GUIDEWIRE. 6. SIMULTANEOUSLY REMOVE THE DILATOR AND 0.018 INCH (0.46 MM) GUIDEWIRE, WHILE HOLDING THE SHEATH PORTION OF THE ASSEMBLY IN PLACE. 7. ADVANCE A 0.035 INCH (0.89 MM) OR 0.038 INCH (0.97 MM) GUIDEWIRE INTO THE SHEATH. 8. REMOVE THE SHEATH, LEAVING THE 0.035 INCH (0.89 MM) OR 0.038 INCH (0.97 MM) WIRE. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(6).
THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4). VOLUNTARY MEDWATCH MW5150404.
A CONFIDENTIAL REPORTER SUBMITTED A USER FACILITY MEDWATCH FOR A MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG. IT WAS REPORTED THAT A THIN PIECE OF WIRE WAS SHEARED OFF DURING INSERTION AND BECAME EMBEDDED IN THE SUBCUTANEOUS TISSUE, BENEATH THE SKIN, AT THE RIGHT INTERNAL JUGULAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1669614 | ANGIODYNAMICS | MINI STICK MAX COAXIAL MICROINTRODUCER KIT | DRE | ANGIODYNAMICS, INC | 5798845 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| H |