MICROPUNCTURE TRANSITIONLESS ACCESS SET
Report
- Report Number
- 1820334-2024-01271
- Event Type
- Injury
- Date Received
- September 26, 2024
- Date of Event
- July 14, 2024
- Report Date
- December 30, 2024
- Manufacturer
- COOK INC
- Product Code
- DYB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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.
ADDITIONAL INFORMATION: D9, H3: THE DEVICE WILL NOT BE RETURNED TO COOK. 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 VIA A MEDWATCH REPORT, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S CATHETER/SHEATH WAS PLACED IN A PATIENT'S RIGHT ARM ON (B)(6) 2024. SEVEN DAYS LATER, THE HUB OF THE CATHETER/SHEATH SEPARATED, AND THE CATHETER/SHEATH MATERIAL REMAINED IN THE PATIENT'S RIGHT ARM. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF THE RETAINED FRAGMENT THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED 11 OCT 2024. THE PATIENT WAS ALREADY HOSPITALIZED WHEN THE EVENT OCCURRED. THE DEVICE WAS NOT USED AS AN ARTERIAL LINE; HOWEVER, IT WAS USED FOR VENOUS ACCESS. THE HUB WAS NOT CONNECTED TO ANYTHING AT THE TIME OF THE EVENT, AND NOTHING WAS BEING INFUSED THROUGH THE DEVICE AT THE TIME OF THE EVENT. IT IS UNKNOWN IF CATHETER MATERIAL REMAINED IN THE HUB. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED TO COOK, AND A GLOBAL SHIPMENT SEARCH WAS UNABLE TO DETERMINE THE LOT; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU STATES THAT THE DEVICE IS INTENDED FOR PLACEMENT OF WIRE GUIDES AND INSTRUCTS THE USER TO REMOVE THE INTRODUCER CATHETER ONCE THE DESIRED WIRE GUIDE IS IN PLACE. 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 AND IFU 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 INTENTIONAL OFF-LABEL USE AND PROCEDURAL ISSUES CONTRIBUTED TO THIS EVENT, AS THE COMPLAINT DEVICE WAS USED AS AN INDWELLING VENOUS LINE. THE IFU STATES THAT THE DEVICE IS INTENDED FOR PLACEMENT OF WIRE GUIDES AND INSTRUCTS THE USER TO REMOVE THE INTRODUCER CATHETER ONCE THE DESIRED WIRE GUIDE IS IN PLACE. BECAUSE INDWELLING VENOUS LINES MUST BE ROUTINELY FLUSHED IF CONTINUOUS INTRAVENOUS FLUIDS ARE NOT BEING ADMINISTERED AND INTRAVENOUS TUBING MUST BE CHANGED ON A REGULAR BASIS (BASED ON INDIVIDUAL HOSPITAL PROTOCOLS), IT IS LIKELY THAT THE CATHETER/SHEATH HUB WAS MANIPULATED ON MULTIPLE OCCASIONS DURING THE SEVEN-DAY PERIOD IN WHICH THE DEVICE WAS LEFT IN PLACE. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5, D9, H3. D9, H3: ADDITIONAL INFORMATION RECEIVED 11OCT2024 INDICATED THAT THE COMPLAINT DEVICE REMAINED AT THE USER FACILITY. IT IS UNCLEAR IF THE DEVICE WILL BE RETURNED TO COOK. 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.
AS REPORTED VIA A MEDWATCH REPORT, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S CATHETER/SHEATH WAS PLACED IN A PATIENT'S RIGHT ARM ON (B)(6) 2024. SEVEN DAYS LATER, THE HUB OF THE CATHETER/SHEATH SEPARATED, AND THE CATHETER/SHEATH MATERIAL REMAINED IN THE PATIENT'S RIGHT ARM. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF THE RETAINED FRAGMENT THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION WAS RECEIVED 11OCT2024. THE PATIENT WAS ALREADY HOSPITALIZED WHEN THE EVENT OCCURRED. THE DEVICE WAS NOT USED AS AN ARTERIAL LINE; HOWEVER, IT WAS USED FOR VENOUS ACCESS. THE HUB WAS NOT CONNECTED TO ANYTHING AT THE TIME OF THE EVENT, AND NOTHING WAS BEING INFUSED THROUGH THE DEVICE AT THE TIME OF THE EVENT. IT IS UNKNOWN IF CATHETER MATERIAL REMAINED IN THE HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1199557 | MICROPUNCTURE TRANSITIONLESS ACCESS SET | DYB INTRODUCER, CATHETER | DYB | COOK INC | G47940 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Male | Required Intervention |