TEITEL PEDIATRIC PERICARDIOCENTESIS CATHETER SET

Report

Report Number: 1820334-2021-02499
Event Type: Death
Date Received: November 15, 2021
Date of Event: January 3, 2019
Report Date: November 10, 2022
Manufacturer: COOK INC
Product Code: GBX
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

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. 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.

Additional Manufacturer Narrative · 0

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. 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.

Additional Manufacturer Narrative · 0

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. 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.

Additional Manufacturer Narrative · 0

PMA/510(K) #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Additional Manufacturer Narrative · 0

INVESTIGATION ¿ EVALUATION: ON 09NOV2022, COOK WAS INFORMED VIA POST MARKET CLINICAL FOLLOW-UP (PMCF) STUDY (B)(6) OF AN ADVERSE EVENT INVOLVING A TEITEL PEDIATRIC PERICARDIOCENTESIS CATHETER SET (RPN: C-PCS-500-TTL; LOT UNKNOWN) PLACED IN A SUBOPTIMAL POSITION AT THE CHILDREN'S HOSPITAL MED. CTR. THE DEVICE WAS REQUIRED BY A 4-MONTH-OLD FEMALE PATIENT FOR A PERICARDIAL DRAIN PLACEMENT IN THE LEFT XIPHOCOSTAL AREA. DURING THE PROCEDURE ON (B)(6) 2019, THE DEVICE WAS PLACED IN THE INCORRECT ANATOMICAL LOCATION. ¿THE MISPLACEMENT ALONG WITH MULTIPLE OTHER FACTORS INDUCED CARDIAC ARREST.¿ BASED ON REAL-TIME ECHOCARDIOGRAPHY, THERE WAS A PERICARDIAL EFFUSION. THEREFORE, THE DRAIN WAS REPLACED IMMEDIATELY. THE FOLLOWING DAY, ON (B)(6) 2019, THE PATIENT EXPIRED. THE REPLACEMENT DRAIN WAS THEN REMOVED FOLLOWING PATIENT DEATH. IT WAS REPORTED THAT MULTIPLE THINGS CONTRIBUTED TO THE PATIENT¿S DEATH INCLUDING REFRACTORY VENTRICULAR TACHYCARDIA, LOW CARDIAC OUTPUT, AND TAMPONADE PHYSIOLOGY. A REVIEW OF INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THIS PRODUCT IS SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET C_T_TTPS_REV10. IN THE PRECAUTIONS SECTION IT STATES: STANDARD PERICARDIOCENTESIS TECHNIQUES SHOULD BE EMPLOYED. IN THE INSTRUCTIONS FOR USE SECTION, IT STATES: INTRODUCE THE CATHETER (WITH STIFFENING CANNULA, IF APPLICABLE) OVER THE WIRE GUIDE AND ADVANCE UNTIL THE TIP OF THE CATHETER IS POSTERIOR TO THE MUSCLE FASCIA. IF THE SET CONTAINS A CATHETER WITH STIFFENING CANNULA, REMOVE THE CANNULA WITH A TWISTING MOTION, WHILE HOLDING THE CATHETER AND WIRE GUIDE IN PLACE. ADVANCE THE CATHETER INTO THE PERICARDIUM. IN THE HOW SUPPLIED SECTION IT STATES: UPON REMOVAL FROM PACKAGE INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDED THERE IS NO INDICATION THE DEVICE FAILED. NO PROBLEM WAS DETECTED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.