ILLUMISITE
Report
- Report Number
- 3004962788-2024-00091
- Event Type
- Malfunction
- Date Received
- August 1, 2024
- Date of Event
- July 19, 2024
- Report Date
- October 28, 2024
- Manufacturer
- COVIDIEN LP - SUPERDIMENSION INC
- Product Code
- JAK
- PMA / PMN Number
- K191394
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION: G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE EWC WAS DAMAGED 390MM FROM THE END OF THE HANDLE. THE INNER BRAID WAS SEVERED. THE EWC HAD BECOME DELAMINATED AT THE LOCATION AS WELL. FUNCTIONAL TESTING FOUND THAT THE INNER DIAMETER OF THE EWC WAS CHECKED WITH A BALL MANDREL, BUT IT WAS UNABLE TO PASS THROUGH THE KINK. IT WAS REPORTED THAT THERE WAS STRING-LIKE FIBER PRESENT AND WOULD NOT ADVANCE. THE REPORTED ISSUES WERE CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE EVALUATION DETECTED AN UNREPORTED CONDITION: OF EWC OPEN THAT HAS NO RELATIONSHIP TO THE REPORTED CONDITION. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER NAVIGATING TO THE TARGET IN THE RIGHT UPPER LOBE, ANTERIOR SEGMENT, THERE WAS SOME RESISTANCE WHILE PUTTING THE ARCPOINT NEEDLE IN. WHEN THE USER MOVED ON THE FORCEPS, THE DEVICE WAS UNABLE TO EXTEND THROUGH THE EXTENDED WORKING CHANNEL (EWC). THE CATHETER WAS TAKEN OUT OF THE SCOPE, AND THE RUBBER LINING WAS COMPLETELY RIPPED. TO RESOLVE THE ISSUE, ANOTHER KIT WAS USED FOR NAVIGATION WITH THE SAME SCOPE. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER NAVIGATING TO THE TARGET IN THE RIGHT UPPER LOBE, ANTERIOR SEGMENT, THERE WAS SOME RESISTANCE WHILE PUTTING THE ARC POINT NEEDLE IN. WHEN THE USER MOVED ON THE FORCEPS, THE DEVICE WAS UNABLE TO EXTEND THROUGH THE EXTENDED WORKING CHANNEL (EWC). THE CATHETER WAS TAKEN OUT OF THE SCOPE, AND THE RUBBER LINING WAS COMPLETELY RIPPED. IT WAS ALSO KINKED. TO RESOLVE THE ISSUE, ANOTHER KIT WAS USED FOR NAVIGATION WITH THE SAME SCOPE. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2076057 | ILLUMISITE | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | JAK | COVIDIEN LP - SUPERDIMENSION INC | ILS-0900-KT | 528509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |