COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
Report
- Report Number
- 3005099803-2011-01520
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- April 14, 2011
- Report Date
- April 14, 2011
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- FDX
- PMA / PMN Number
- K930348
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE BRUSH RETRACTED, AND THE CATHETER WAS KINKED IN SEVERAL LOCATIONS ALONG THE WORKING LENGTH. THE HANDLE CANNULA WAS BENT. DURING FUNCTIONAL TESTING, RESISTANCE WAS ENCOUNTERED WHEN THE BRUSH WAS EXTENDED AND RETRACTED. THE DEVICE COULD NOT BE FULLY INSERTED INTO A DUODENOSCOPE DUE TO THE KINKS IN THE WORKING LENGTH. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WAS KINKED AND DIFFICULT TO ADVANCE; THE COMPLAINT WAS CONFIRMED. THE WORKING LENGTH CAN BECOME KINKED IF TOO MUCH CATHETER LENGTH IS INSERTED INTO THE SCOPE TOO QUICKLY, AND THIS CAN IMPEDE THE DEVICE'S BEING ADVANCED THROUGH THE SCOPE TO THE DESIRED LOCATION. ADDITIONALLY, A KINKED WORKING LENGTH CAN IMPEDE MOVEMENT OF THE DRIVE WIRE WITHIN THE CATHETER, AND ATTEMPTS TO ACTUATE THE HANDLE CAN CAUSE THE HANDLE CANNULA TO BEND. THE MOST PROBABLE ROOT CAUSE FOR THE IDENTIFIED DEFECTS IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN COULD NOT ADVANCE THE CYTOLOGY BRUSH OVER THE GUIDEWIRE MORE THAN A CENTIMETER OR TWO INTO THE COMMON BILE DUCT, WHICH WAS REPORTED TO TURN SHARPLY. ADDITIONALLY, THE CATHETER WAS VISIBLY KINKED TOWARDS THE DEVICE TIP. THE PATIENT'S ANATOMY WAS REPORTED TO BE DISTORTED, AS THE INDICATION FOR THE PROCEDURE WAS COLON CANCER WITH LIVER INVOLVEMENT. THE GUIDEWIRE WAS KEPT IN PLACE, THE BRUSH WAS REMOVED, AND A SECOND RX CYTOLOGY BRUSH WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE ACCOUNT ALLEGES NO MALFUNCTION OF THE GUIDEWIRE THAT WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN COULD NOT ADVANCE THE CYTOLOGY BRUSH OVER THE GUIDEWIRE MORE THAN A CENTIMETER OR TWO INTO THE COMMON BILE DUCT, WHICH WAS REPORTED TO TURN SHARPLY. ADDITIONALLY, THE CATHETER WAS VISIBLY KINKED TOWARDS THE DEVICE TIP. THE PATIENT'S ANATOMY WAS REPORTED TO BE DISTORTED, AS THE INDICATION FOR THE PROCEDURE WAS COLON CANCER WITH LIVER INVOLVEMENT. THE GUIDEWIRE WAS KEPT IN PLACE, THE BRUSH WAS REMOVED, AND A SECOND RX CYTOLOGY BRUSH WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE ACCOUNT ALLEGES NO MALFUNCTION OF THE GUIDEWIRE THAT WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM | ENDOSCOPIC CYTOLOGY BRUSH | FDX | BOSTON SCIENTIFIC - SPENCER | M00545000 | 14082686 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |