MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
Report
- Report Number
- 1820334-2022-00662
- Event Type
- Injury
- Date Received
- April 27, 2022
- Date of Event
- April 15, 2022
- Report Date
- July 11, 2022
- Manufacturer
- COOK INC
- Product Code
- KRA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CUSTOMER NAME AND ADDRESS: (B)(6). PMA/510(K) NUMBER = K182071. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. EVENT SUMMARY AS REPORTED, A PATIENT WITH DEEP VEIN THROMBOSIS UNDERWENT A THROMBOLYSIS PROCEDURE IN WHICH A MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET WAS USED. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT, THE USER NOTICED A RADIOPAQUE MARKER BAND WITHIN THE VESSELS. THE SEPARATED MARKER BAND MIGRATED TO THE DORSALIS PEDIS ARTERY. NO ACTION WAS TAKEN. PER THE INITIAL REPORTER, THE PATIENT HAS HAD NO SYMPTOMS RELATED TO THE RETAINED MARKER BAND. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION - EVALUATION A DOCUMENT-BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), DRAWING, MANUFACTURING INSTRUCTIONS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. IN RESPONSE TO THIS INCIDENT, A GLOBAL SHIPMENT SEARCH ON THE USER FACILITY AND COMPLAINT DEVICE WAS PERFORMED AS NO LOT NUMBER WAS GIVEN. COOK FOUND 3 POSSIBLE LOTS SHIPPED TO THE COMPLAINANT. THERE WERE NO RELEVANT NON-CONFORMANCES FOR ANY OF THE 3 AND A DATABASE SEARCH FOUND THERE WERE NO LOT RELATED COMPLAINTS FROM THE FIELD FOR ANY OF THESE 3 LOTS AS WELL. OF THE CATHETER COMPONENT LOTS ASSOCIATED WITH THE COMPLAINT LOT ONLY ONE RECORDS THREE RELEVANT NON-CONFORMANCES FOR SHAFT DAMAGE. ALTHOUGH THESE NON-CONFORMANCES ARE RELEVANT TO THE REPORTED FAILURE MODE, ALL NON-CONFORMING PRODUCT WAS SCRAPPED, THERE ARE 100% INSPECTIONS TO CAPTURE THIS NON-CONFORMANCE, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, AND THERE ARE NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD. THE MARKER BANDS FOR THIS DEVICE ARE ATTACHED EXTERNALLY TO THE CATHETER SHAFT DURING MANUFACTURING. DUE TO THIS, A LIST OF ALL LOTS COMPLETED BY THE SAME OPERATOR AS THE THREE POTENTIAL COMPLAINT LOTS FOUND FOUR ADDITIONAL LOTS MANUFACTURED ON THE SAME DAY. THESE FOUR ADDITIONAL LOTS DID NOT HAVE ANY RELEVANT NONCONFORMANCE, OR ANY COMPLAINTS REPORTED FROM THE FIELD. AT THIS TIME, COOK HAS CONCLUDED THIS TO BE A SINGULAR INCIDENT, THUS NO ESCALATION IS RECOMMENDED. DEFECT AWARENESS WAS COMPLETED ON (B)(6) 2022 FOR THE EMPLOYEE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: ¿DUE TO THE "THIN WALL" CONSTRUCTION OF THE MULIT-SIDEPORT CATHETER, CARE MUST BE EXERCISED DURING MANIPULATION AND WITHDRAWAL TO PREVENT CATHETER DAMAGE.¿ PRECAUTIONS: ¿DO NOT INSERT, MANIPULATE OR WITHDRAW THE MULTI-SIDEPORT WITHOUT THE USE OF A WIRE GUIDE.¿ ¿IF RESISTANCE IS FELT BETWEEN THE VESSEL AND THE CATHETER, OR BETWEEN THE CATHETER AND THE WIRE GUIDE, DO NOT ATTEMPT TO USE FORCE, AS THE VESSEL, THE CATHETER OR THE WIRE GUIDE MAY BECOME DAMAGED.¿ ¿DO NOT INJECT CONTRAST WITH A POWER INJECTOR THROUGH THE TUOHY-BORST ADAPTER, OR WHEN THE TIP OCCLUDER IS IN PLACE. DAMAGE TO THE VESSEL MAY OCCUR.¿ COOK HAS CONCLUDED THAT A MANUFACTURING DEFICIENCY CONTRIBUTED TO THE FAILURE MODE. RESPONSIBLE PERSONNEL HAVE BEEN RETRAINED TO PREVENT THIS FROM OCCURRING AGAIN IN THE FUTURE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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.
AS REPORTED, A PATIENT WITH DEEP VEIN THROMBOSIS UNDERWENT A THROMBOLYSIS PROCEDURE IN WHICH A MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET WAS USED. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT, THE USER NOTICED A RADIOPAQUE MARKER BAND WITHIN THE VESSELS. THE SEPARATED MARKER BAND MIGRATED TO THE DORSALIS PEDIS ARTERY. NO ACTION WAS TAKEN. PER THE INITIAL REPORTER, THE PATIENT HAS HAD NO SYMPTOMS RELATED TO THE RETAINED MARKER BAND. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
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 |
|---|---|---|---|---|---|---|---|
| 1085108 | MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET | KRA CATHETER, CONTINUOUS FLUSH | KRA | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |