CRE BALLOON DILATATION CATHETER
Report
- Report Number
- 3005099803-2011-01472
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Report Date
- April 5, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- KNQ
- PMA / PMN Number
- K971320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
Narratives
PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. THE ACCOUNT COULD NOT PROVIDE THE EVENT/PROCEDURE DATE. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED WITH COMPLAINT DEVICE AS DILATATION WAS COMPLETE. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE CATHETER OF THE DEVICE HAD TWO KINKS. THE FUNCTIONAL TEST FOR CATHETER PASSAGE THROUGH ENDOSCOPE COULD NOT BE PERFORMED AS THE BALLOON WAS NO LONGER IN ITS WINGFOLDED CONFIGURATION. ALSO, CONSISTENT WITH THE COMPLAINANTS REPORT, THE CATHETER WAS CUT THROUGH THE DISTAL TIP OF THE BALLOON AND GUIDEWIRE THEREFORE EVALUATION OF THE REPORTED DEFLATION FAILURE COULD NOT BE PERFORMED. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION THAT DEFLATION ISSUES WERE ENCOUNTERED NOT ALLOWING THE DEVICE TO BE PULLED THROUGH THE SCOPE. THE ROOT CAUSED OF THIS COMPLAINT IS OPERATIONAL CONTEXT AS PROCEDURAL FACTORS LIKELY LEAD TO DEFLATION FAILURE OF THE BALLOON. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A CRE FIXED WIRE BALLOON DILATATION CATHETER WAS USED DURING A PROCEDURE PREFORMED ON PATIENT (PROCEDURE NAME AND DATE ARE UNKNOWN; PATIENT AGE, GENDER, WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THEY COMPLETED DILATING THE ESOPHAGUS AND WERE TRYING TO DEFLATE THE BALLOON; HOWEVER THE BALLOON WOULD NOT COMPLETELY DEFLATE. THE INFLATION MEDIA WAS CONSOLIDATED AT THE END OF THE BALLOON AND THE BALLOON MATERIAL BUNCHED AT THE END. THE BALLOON COULD NOT BE REMOVED FROM THE SCOPE. THE SCOPE WAS REMOVED WITH THE BALLOON INSIDE, AND THE BALLOON TIP WAS CUT IN ORDER TO REMOVE THE DEVICE. THERE WERE NO OTHER VISIBLE ISSUES NOTED TO THE DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A CRE FIXED WIRE BALLOON DILATATION CATHETER WAS USED DURING A PROCEDURE PREFORMED ON PATIENT (PROCEDURE NAME AND DATE ARE UNKNOWN; PATIENT AGE, GENDER, WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THEY COMPLETED DILATING THE ESOPHAGUS AND WERE TRYING TO DEFLATE THE BALLOON; HOWEVER THE BALLOON WOULD NOT COMPLETELY DEFLATE. THE INFLATION MEDIA WAS CONSOLIDATED AT THE END OF THE BALLOON AND THE BALLOON MATERIAL BUNCHED AT THE END. THE BALLOON COULD NOT BE REMOVED FROM THE SCOPE. THE SCOPE WAS REMOVED WITH THE BALLOON INSIDE, AND THE BALLOON TIP WAS CUT IN ORDER TO REMOVE THE DEVICE. THERE WERE NO OTHER VISIBLE ISSUES NOTED TO THE DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRE BALLOON DILATATION CATHETER | DILATOR, ESOPHAGEAL | KNQ | BOSTON SCIENTIFIC - MARLBOROUGH | M00558380 | 14005702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |