RESOLUTION HEMOSTASIS CLIPPING DEVICE
Report
- Report Number
- 3005099803-2011-00333
- Event Type
- Injury
- Date Received
- February 16, 2011
- Date of Event
- January 23, 2011
- Report Date
- January 24, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- MND
- PMA / PMN Number
- K040148
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- PHYSICIAN
Narratives
ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON 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.
A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS FULLY DEPLOYED, AS THE CONTROL WIRE WAS SEPARATED PER DESIGN, AND WAS NOT RETURNED WITH THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED; THE INFORMATION REASONABLY SUGGESTS THAT THE CLINICAL EVENT IS ANTICIPATED IN NATURE AND SEVERITY AND THE DEVICE WAS USED IN ACCORDANCE WITH THE DEVICE LABELING. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, IT IS PROBABLE THAT THE FAILURE OF THE CLIP TO RELEASE FROM THE CATHETER WAS DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.
NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-00334 FOR THE ASSOCIATED DEVICE REPORT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED TO TREAT A BLEED IN THE ESOPHAGUS DURING AN UPPER ENDOSCOPY PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS ADVANCED FROM ITS OVER SHEATH AND GRASPED TISSUE. THE PHYSICIAN ATTEMPTED TO DEPLOY THE CLIP FROM ITS DELIVERY CATHETER ONTO THE TISSUE; HOWEVER, IT WOULD NOT RELEASE FROM THE CATHETER. THE CLIP WAS REMOVED FROM THE TISSUE; HOWEVER, THIS MANIPULATION CAUSED THE TISSUE TO TEAR, RESULTING IN ADDITIONAL BLEEDING. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT. A SECOND RESOLUTION CLIP WAS USED, HOWEVER THE SAME ISSUE OCCURRED. THE PHYSICIAN USED ANOTHER MANUFACTURER'S CLIP TO STOP THE BLEEDING AND SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE CONCLUSION OF THE PROCEDURE.
NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-00334 FOR THE ASSOCIATED DEVICE REPORT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED TO TREAT A BLEED IN THE ESOPHAGUS DURING AN UPPER ENDOSCOPY PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP WAS ADVANCED FROM ITS OVER SHEATH AND GRASPED TISSUE. THE PHYSICIAN ATTEMPTED TO DEPLOY THE CLIP FROM ITS DELIVERY CATHETER ONTO THE TISSUE; HOWEVER, IT WOULD NOT RELEASE FROM THE CATHETER. THE CLIP WAS REMOVED FROM THE TISSUE; HOWEVER, THIS MANIPULATION CAUSED THE TISSUE TO TEAR, RESULTING IN ADDITIONAL BLEEDING. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT. A SECOND RESOLUTION CLIP WAS USED, HOWEVER THE SAME ISSUE OCCURRED. THE PHYSICIAN USED ANOTHER MANUFACTURER'S CLIP TO STOP THE BLEEDING AND SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE CONCLUSION OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESOLUTION HEMOSTASIS CLIPPING DEVICE | LIGATOR, ESOPHAGEAL | MND | BOSTON SCIENTIFIC - MARLBOROUGH | M00522611 | 10071301C2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |