MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
Report
- Report Number
- 1820334-2020-00265
- Event Type
- Injury
- Date Received
- February 3, 2020
- Date of Event
- January 20, 2020
- Report Date
- April 22, 2020
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002480070
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
INITIAL REPORT: AS REPORTED, DURING ATTEMPTED INTERNAL JUGULAR ACCESS, A COOK MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET GUIDE FRAYED AND SPLIT. THE PHYSICIAN REPORTEDLY BELIEVES THAT THE DRY, COLLAPSED NATURE OF THE VESSEL COMBINED WITH THE FLOPPY TIP OF THE WIRE RESULTED IN THE DEVICE GOING THROUGH THE VESSEL. THE PHYSICIAN BELIEVES THAT THE DEVICE THEN BECAME LODGED EITHER OUTSIDE OR BETWEEN THE VESSEL WALL(S). AS THE USER ATTEMPTED TO REMOVE THE WIRE THROUGH THE NEEDLE, RESISTANCE WAS ENCOUNTERED. THE USER THEN ATTEMPTED TO REMOVE THE NEEDLE ONLY AND RESISTANCE WAS ENCOUNTERED. THE WIRE AND NEEDLE WERE THEN REMOVED TOGETHER, AT WHICH POINT THE TIP OF THE WIRE SEPARATED AND FRAYED, LEAVING THE TIP OF THE WIRE IN THE PATIENT. A SURGICAL CONSULT WAS OBTAINED, AND EMERGENCY SURGERY WAS DETERMINED TO BE NECESSARY TO SAFELY RETRIEVE THE SEPARATED PORTION OF THE WIRE. THE USER REPORTEDLY ATTRIBUTES THE NEED FOR SURGERY TO THE ANATOMICAL CONDITIONS OF THE PATIENT. INVESTIGATION / EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOTE ONE POTENTIALLY RELATED NONCONFORMANCE FOR A SEPARATED COIL. WHILE THIS NONCONFORMANCE IS POTENTIALLY RELATED, IT SHOULD BE NOTED THAT THE AFFECTED UNITS WERE SCRAPPED AND NOT REPLACED. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE PROVIDES EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. AN IFU IS PROVIDED WITH THIS DEVICE, WHICH STATES, ¿DO NOT WITHDRAW THE WIRE GUIDE THROUGH THE INTRODUCER NEEDLE; BREAKAGE MAY RESULT. IF THE WIRE GUIDE TIP MUST BE WITHDRAWN WHILE THE NEEDLE IS INSERTED, REMOVE BOTH THE NEEDLE AND THE WIRE AS A UNIT.¿ BASED ON THE AVAILABLE INFORMATION, INVESTIGATION HAS CONCLUDED THAT A POTENTIAL CAUSE CAN BE TRACED TO THE PROCEDURE AND/OR PATIENT ANATOMY. IT WAS STATED THAT THE PATIENT'S VESSEL WAS "DRY, " AND RESISTANCE WAS FELT WHEN REMOVING THE WIRE THROUGH THE NEEDLE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND / OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION WAS RECEIVED 06FEB2020. THE PATIENT WAS IN CRITICAL CARE AND THE DEVICE WAS USED TO OBTAIN INTERNAL JUGULAR ACCESS. REPORTEDLY, THE VEIN WAS ¿DRY¿, AND STANDARD METHODS OF ACCESS HAD FAILED. THE PHYSICIAN REPORTEDLY BELIEVES THAT THE DRY, COLLAPSED NATURE OF THE VESSEL COMBINED WITH THE FLOPPY TIP OF THE WIRE RESULTED IN THE DEVICE GOING THROUGH THE VESSEL. THE PHYSICIAN BELIEVES THAT THE DEVICE THEN BECAME LODGED EITHER OUTSIDE OR BETWEEN THE VESSEL WALL(S). AS THE USER ATTEMPTED TO REMOVE THE WIRE THROUGH THE NEEDLE, RESISTANCE WAS ENCOUNTERED. THE USER THEN ATTEMPTED TO REMOVE THE NEEDLE ONLY AND RESISTANCE WAS ENCOUNTERED. THE WIRE AND NEEDLE WERE THEN REMOVED TOGETHER, AT WHICH POINT THE TIP OF THE WIRE SEPARATED AND FRAYED, LEAVING THE TIP OF THE WIRE IN THE PATIENT. A SURGICAL CONSULT WAS OBTAINED, AND EMERGENCY SURGERY WAS DETERMINED TO BE NECESSARY TO SAFELY RETRIEVE THE SEPARATED PORTION OF THE WIRE. THE USER REPORTEDLY ATTRIBUTES THE NEED FOR SURGERY TO THE ANATOMICAL CONDITIONS OF THE PATIENT.
PER THE INITIAL REPORTER, IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. (B)(6). REPORTER OCCUPATION = PROGRAM MANAGER. PMA/510(K) NUMBER = K171275. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, DURING AN UNKNOWN PROCEDURE, A COOK MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET GUIDE FRAYED AND SPLIT. THE GUIDE WIRE WAS REPORTEDLY DIFFICULT TO ADVANCE OR RETRACT DURING PLACEMENT, THEREFORE, THE PHYSICIAN PULLED THE INTRODUCER FROM THE WIRE. AT THAT POINT, THE GUIDE WAS NOTED TO BE FRAYED AND SPLIT LONGITUDINALLY. THE PHYSICIAN CLAMPED THE WIRE AND OBTAINED A VASCULAR CONSULT. THE PATIENT UNDERWENT AN EMERGENT SURGICAL PROCEDURE TO REMOVE THE DEVICE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 120902 | MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET | DYB INTRODUCER, CATHETER | DYB | COOK INC | G48007 | 8871160 | 00827002480070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |