MICROPUNCTURE TRANSITIONLESS ACCESS SET
Report
- Report Number
- 1820334-2024-01593
- Event Type
- Injury
- Date Received
- December 4, 2024
- Report Date
- April 11, 2025
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002535787
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
E3: OCCUPATION = PURCHASING BUYER. G4: PMA/510(K) NUMBER = K240589. 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.
SUMMARY OF EVENT: AS REPORTED, DURING PLACEMENT OF A PERCUTANEOUS CENTRAL LINE IN THE LEFT FEMORAL VEIN, A MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S WIRE UNRAVELED UPON REMOVAL. ULTRASOUND GUIDED ACCESS WAS OBTAINED IN THE LEFT FEMORAL VEIN, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO INSERTION AND ADVANCEMENT OF THE WIRE GUIDE. THE ACCESS SITE WAS REPORTEDLY NORMAL, AND NO PRIOR ATTEMPTS HAD BEEN MADE TO OBTAIN VASCULAR ACCESS AT THE SITE. THE USER ATTEMPTED TO REMOVE THE WIRE THROUGH THE ENTRY/ACCESS NEEDLE, AND RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE ¿LAST PART¿ OF THE WIRE, AT WHICH POINT THE MIDDLE SECTION OF THE WIRE UNRAVELED AND BECAME STUCK. PER THE REPORTER, THE WIRE WAS ABLE TO BE REMOVED MANUALLY THROUGH THE ENTRY NEEDLE, WITH THE END OF THE WIRE INTACT. A NEW WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. REPORTEDLY, THE PATIENT DEVELOPED A HEMATOMA AROUND THE ACCESS SITE BECAUSE OF THE EVENT, WITH SUBSEQUENT DISCOLORATION OF THE LEG. DIRECT PRESSURE WAS APPLIED FOR ¿SOME TIME¿, THE LIMB WAS ELEVATED, AND WARM COMPRESSES WERE APPLIED. EXTRA CLINICAL MONITORING WAS REQUIRED, INCLUDING USE OF ULTRASOUND AND DOPPLER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE WIRE WAS UNRAVELED, BEGINNING AT THE SOLDER POINT; HOWEVER, THE WIRE WAS NOT SEPARATED AND WAS HELD TOGETHER BY UNRAVELED COILS. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE FINAL OR SUB-ASSEMBLY LOTS. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU CAUTIONS ¿WITHDRAW OR MANIPULATION OF THE DISTAL SPRING COIL PORTION OF THE MANDRIL WIRE GUIDE THROUGH A NEEDLE TIP MAY RESULT IN BREAKAGE.¿ THE IFU ALSO STATES ¿CAUTION: 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.¿ A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT FAILURE TO FOLLOW INSTRUCTIONS CONTRIBUTED TO THIS EVENT, AS THE USER ATTEMPTED TO REMOVE THE WIRE THROUGH THE ACCESS NEEDLE. THE IFU STATES ¿CAUTION: 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.¿ THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
AS REPORTED, DURING PLACEMENT OF A PERCUTANEOUS CENTRAL LINE IN THE LEFT FEMORAL VEIN, A MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S WIRE UNRAVELED UPON REMOVAL. ULTRASOUND GUIDED ACCESS WAS OBTAINED IN THE LEFT FEMORAL VEIN, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO INSERTION AND ADVANCEMENT OF THE WIRE GUIDE. THE ACCESS SITE WAS REPORTEDLY NORMAL, AND NO PRIOR ATTEMPTS HAD BEEN MADE TO OBTAIN VASCULAR ACCESS AT THE SITE. THE USER ATTEMPTED TO REMOVE THE WIRE THROUGH THE ENTRY/ACCESS NEEDLE, AND RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE ¿LAST PART¿ OF THE WIRE, AT WHICH POINT THE MIDDLE SECTION OF THE WIRE UNRAVELED AND BECAME STUCK. PER THE REPORTER, THE WIRE WAS ABLE TO BE REMOVED MANUALLY THROUGH THE ENTRY NEEDLE, WITH THE END OF THE WIRE INTACT. A NEW WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. REPORTEDLY, THE PATIENT DEVELOPED A HEMATOMA AROUND THE ACCESS SITE BECAUSE OF THE EVENT, WITH SUBSEQUENT DISCOLORATION OF THE LEG. DIRECT PRESSURE WAS APPLIED FOR ¿SOME TIME¿, THE LIMB WAS ELEVATED, AND WARM COMPRESSES WERE APPLIED. EXTRA CLINICAL MONITORING WAS REQUIRED, INCLUDING USE OF ULTRASOUND AND DOPPLER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2049679 | MICROPUNCTURE TRANSITIONLESS ACCESS SET | DYB INTRODUCER, CATHETER | DYB | COOK INC | G53578 | 16228262 | 00827002535787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O |