CXI SUPPORT CATHETER
Report
- Report Number
- 1820334-2022-01123
- Event Type
- Injury
- Date Received
- June 28, 2022
- Date of Event
- June 14, 2022
- Report Date
- August 15, 2022
- Manufacturer
- COOK INC
- Product Code
- KRA
- PMA / PMN Number
- K122796
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
COMMON NAME & PRODUCT CODE = ALTHOUGH THE EXACT RPN IS UNKNOWN, THE PRODUCT CODE FOR ALL CXI SUPPORT CATHETERS IS KRA. OCCUPATION = LAB MANAGER. PMA/510(K) NUMBER = ALTHOUGH THE EXACT RPN IS UNKNOWN, THE 510(K) FOR "014" CXI SUPPORT CATHETERS IS K122796. 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: D4: A SEARCH OF SALES DATA/HISTORY FOR THIS CUSTOMER HAS DETERMINED THAT THE COMPLAINT DEVICE WAS EITHER A CXI-2.3-14-150-0 OR A CXI-2.3-14-150-ANG. SUMMARY OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE, AN UNSPECIFIED "014" CXI SUPPORT CATHETER SEPARATED WHILE PULLING THE DEVICE FROM THE PATIENT. ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY TO TARGET THE ANTERIOR TIBIAL ARTERY. THE ANATOMY WAS REPORTEDLY CALCIFIED. AN UNKNOWN PEDAL SHEATH WAS PLACED IN THE ANTERIOR TIBIAL ARTERY AND ANOTHER MANUFACTURER¿S 6X65 SHEATH WAS USED WITH THE COMPLAINT DEVICE. A POWER INJECTOR WAS USED; HOWEVER, WAS NOT IN USE AT THE TIME OF SEPARATION. HAND INJECTION WAS REPORTEDLY BEING PERFORMED VIA TIBIAL ACCESS WHEN THE EVENT OCCURRED. WHILE TRYING TO CROSS THE LESION, THE DEVICE BECAME STUCK AND SEPARATED TOWARD THE TIP UPON REMOVAL OF THE DEVICE. RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE DEVICE, AT WHICH POINT IT STRETCHED AND SEPARATED. THE SEPARATED CATHETER WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY BY PULLING IT OUT WITH ANOTHER CATHETER, AND THE PROCEDURE WAS CONTINUED. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION; HOWEVER, AN IMAGE WAS PROVIDED BY THE CUSTOMER, SHOWING THAT THE CATHETER SEPARATED TOWARD THE MIDDLE OF THE SHAFT. A DEVICE MASTER RECORD (DMR) REVIEW AS PERFORMED FOR THE POSSIBLE RPNS, AND DEVICE MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL PROCEDURES ASSOCIATED WITH THE COMPLAINT WERE IDENTIFIED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICE. COOK REVIEWED THE SALES HISTORY FOR THE CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE PRODUCT IFU STATES ¿THE CATHETER SHOULD NOT BE ADVANCED THROUGH AN AREA OF RESISTANCE UNLESS THE SOURCE OF RESISTANCE IS IDENTIFIED BY FLUOROSCOPY AND APPROPRIATE STEPS ARE TAKEN TO REDUCE OR REMOVE THE OBSTRUCTION.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, IFU, AND INSPECTION OF THE PHOTO PROVIDED BY THE CUSTOMER 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 THE PATIENT¿S CONDITION AND THE PROCEDURE CONTRIBUTED TO THIS INCIDENT, AS THE ANATOMY WAS CALCIFIED, AND THE CATHETER BECAME STUCK WHILE ATTEMPTING TO CROSS THE LESION. 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.
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, DURING AN UNKNOWN PROCEDURE, AN UNSPECIFIED "014" CXI SUPPORT CATHETER SEPARATED WHILE PULLING THE DEVICE FROM THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS REPORT WAS SUBMITTED.
ADDITIONAL INFORMATION WAS RECEIVED 08JUL2022. ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY TO TARGET THE ANTERIOR TIBIAL ARTERY. THE ANATOMY WAS REPORTEDLY CALCIFIED. AN UNKNOWN PEDAL SHEATH WAS PLACED IN THE ANTERIOR TIBIAL ARTERY AND ANOTHER MANUFACTURER¿S 6X65 SHEATH WAS USED WITH THE COMPLAINT DEVICE. A POWER INJECTOR WAS USED; HOWEVER, WAS NOT IN USE AT THE TIME OF SEPARATION. HAND INJECTION WAS REPORTEDLY BEING PERFORMED VIA TIBIAL ACCESS WHEN THE EVENT OCCURRED. WHILE TRYING TO CROSS THE LESION, THE DEVICE BECAME STUCK AND SEPARATED TOWARD THE TIP UPON REMOVAL OF THE DEVICE. RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE DEVICE, AT WHICH POINT IT STRETCHED AND SEPARATED. THE SEPARATED CATHETER WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY BY PULLING IT OUT WITH ANOTHER CATHETER, AND THE PROCEDURE WAS CONTINUED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1939183 | CXI SUPPORT CATHETER | KRA CATHETER, CONTINUOUS FLUSH | KRA | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | 6X65 DESTINATION SHEATH, 0.014 |