PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
Report
- Report Number
- 2029046-2018-02233
- Event Type
- Injury
- Date Received
- October 31, 2018
- Date of Event
- October 4, 2018
- Report Date
- October 4, 2018
- Manufacturer
- BIOSENSE WEBSTER INC.
- Product Code
- MTD
- UDI-DI
- 10846835012255
- PMA / PMN Number
- K123837
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
ON 1/16/2019, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE LOT NUMBER OF THE INVOLVED DEVICE IS 30072104L. ON 1/25/2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS FOUND THAT ¿2 OF THE SPLINES HAVE WIRES EXPOSED.¿ THE FINDINGS HAVE BEEN ASSESSED AS MDR REPORTABLE MALFUNCTIONS. DEVICE EVALUATION DETAILS: IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND A MEDICAL DEVICE ENTRAPMENT REQUIRING EXCESSIVE MANIPULATION OCCURRED. THE CATHETER TIPS (SPINES) BECAME DETACHED AND DISLODGED INTO THE PATIENT¿S BODY. DURING THE MAPPING PHASE OF THE ATRIAL TACHYCARDIA IN THE LEFT ATRIUM, IT WAS REPORTED THAT THE SPINES OF PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER GOT CAUGHT IN A PROSTHETIC VALVE CAUSING IT TO TEMPORARILY CEASE FUNCTIONING. THE DOCTOR DECIDED TO PULL THE CATHETER FROM THE PATIENT¿S BODY AND DISCOVERED THAT TWO SPINES, INCLUDING THE ELECTRODES WERE BROKEN OFF AND REMAINED IN THE PATIENT¿S BODY. ONE OF THE PIECES WAS IN THE DESCENDING AORTA AND ONE IN THE INTERCOSTAL ARTERY. A SNARE WAS USED TO REMOVE BOTH PIECES. THERE WERE NO PATIENT CONSEQUENCES AND IT WAS CONFIRMED THAT NO ITEMS REMAINED IN THE PATIENT. THE DEVICE EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS INSPECTED AND TWO SPLINES WERE OBSERVED BROKEN AND WITH INTERNAL PARTS EXPOSED. AS SUCH, THE CUSTOMER COMPLAINT IS CONFIRMED. THE ROOT CAUSE OF THE SPLINE DETACHED COULD BE RELATED TO THE PROCEDURE, SINCE THE INSTRUCTIONS FOR USE STATE THAT THE PENTARAY¿ CATHETERS SHOULD NOT BE USE IN PATIENTS WITH PROSTHETIC VALVES. IN ADDITION, THE PHYSICIAN COMMENTED THAT HE KNEW THAT THE PENTARAY NAV ECO¿S USE FOR PROSTHETIC VALVE WAS A CONTRAINDICATION, HE HAD HEARD THE ANNOUNCEMENT BEFORE BUT FORGOTTEN. SINCE IT IS ALSO DESCRIBED IN THE PACKAGE INSERT, IT IS THE RESPONSIBILITY OF THE DOCTOR. IN THE FUTURE, WE WILL NOT ABLATE PATIENTS TO PROSTHETIC VALVES. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. DURING MANUFACTURING PROCESS, ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS AND FUNCTIONAL TESTS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE FROM LEAVING THE FACILITY. MANUFACTURER¿S REF # (B)(4).
ON 11/8/2018, ADDITIONAL INFORMATION ABOUT THE PATIENT AND EVENT WERE RECEIVED. IT WAS CONFIRMED THAT NO PATIENT CONSEQUENCE OCCURRED AFTER THE PROCEDURE AND SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE ENTRAPPED SPINES. MANUFACTURER¿S REF # (B)(4).
NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. (B)(4). MANUFACTURER'S REF. NO: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND A MEDICAL DEVICE ENTRAPMENT REQUIRING EXCESSIVE MANIPULATION OCCURRED. THE CATHETER TIPS (SPINES) BECAME DETACHED AND DISLODGED INTO THE PATIENT¿S BODY. THIS EVENT IS MDR REPORTABLE. DURING THE MAPPING PHASE OF THE ATRIAL TACHYCARDIA IN THE LEFT ATRIUM, IT WAS REPORTED THAT THE SPINES OF PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER GOT CAUGHT IN A PROSTHETIC VALVE CAUSING IT TO TEMPORARILY CEASE FUNCTIONING. THE DOCTOR DECIDED TO PULL THE CATHETER FROM THE PATIENT¿S BODY AND DISCOVERED THAT TWO SPINES, INCLUDING THE ELECTRODES WERE BROKEN OFF AND REMAINED IN THE PATIENT¿S BODY. ONE OF THE PIECES WAS IN THE DESCENDING AORTA AND ONE IN THE INTERCOSTAL ARTERY. A SNARE WAS USED TO REMOVE BOTH PIECES. THERE WERE NO PATIENT CONSEQUENCES AND IT WAS CONFIRMED THAT NO ITEMS REMAINED IN THE PATIENT. AFTER THAT, THE PROCEDURE CONTINUED, ABLATION WAS CONDUCTED FOR THE ATRIAL TACHYCARDIA AND PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION WITH NO ABNORMALITIES. PER THE INSTRUCTIONS FOR USE OF THE PENTARAY¿ CATHETERS, UNDER THE CONTRAINDICATIONS SECTION, "DO NOT USE PENTARAY¿ CATHETERS IN PATIENTS WITH PROSTHETIC VALVES." THE PHYSICIAN COMMENTED THAT HE KNEW THAT THE PENTARAY NAV ECO¿S USE FOR PROSTHETIC VALVE WAS A CONTRAINDICATION, HE HAD HEARD THE ANNOUNCEMENT BEFORE BUT HAD FORGOTTEN. SINCE IT IS ALSO DESCRIBED IN THE PACKAGE INSERT, IT IS THE RESPONSIBILITY OF THE DOCTOR. IN THE FUTURE, THEY WILL NOT ABLATE PATIENTS WITH PROSTHETIC VALVES. THE ISSUE OF SPINES BREAKING OFF FROM THE CATHETER AND THE ISSUE OF EXCESSIVE CATHETER MANIPULATION TO RETRACT THE CATHETER ARE CONSIDERED MDR REPORTABLE MALFUNCTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863795 | PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER | CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY | MTD | BIOSENSE WEBSTER INC. | 30072104L | 10846835012255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |