N
Patient 1
(B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.
MAUDE MDR 6017439
- MDR report key
- 6017439
- Report number
- 2242352-2016-00978
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-09-04
- Date received
- 2016-10-11
- Adverse event
- 1
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-10-11 | 0 | D |
Event Narratives#
D
Patient 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ON (B)(6) 2016, AFTER THE HEART TRANSPLANT, THE CUSTOMER USED THE AORTIC CUTTER (AC-3038) TO USE A HEARTSTRING III AT THE POINT OF 20MM AWAY FROM THE AORTA END-TO-END ANASTOMOSIS SITE AT THE DONOR SIDE, AND RIGHT AFTER, MASSIVE BLEEDING OCCURRED WITH UNKNOWN CAUSE. THE CUSTOMER TRIED TO STOP BLEEDING AND FOUND THAT THE SUTURE THREAD (PRONOVA4.0) USED FOR THE ANASTOMOSIS WAS CUT OFF AND THE AORTA WAS TORN. DUE TO THIS DAMAGE, THE CUSTOMER SWITCHED TO ON-PUMP, CLAMPED THE AORTA AND RE-ANASTOMOSED THE SITE. THEN, BLEEDING STOPPED. MORE THAN 20-UNIT BLOOD TRANSFUSION WAS PROVIDED AT THE OXYGENATOR SIDE. BEFORE USING THE AC-3038 CUTTER, THE CUSTOMER CHECKED THE AORTIC DIAMETER MORE THAN 25MM (THE ACTUAL MEASUREMENT WAS 30-35MM) AND THE BLOOD PRESSURE OF 50-55MMHG. AS THE PROCEDURE WAS SWITCHED FROM CABG TO ON-PUMP, THE CUSTOMER FINISHED THE SURGERY WITHOUT USING THE HEARTSTRING III. FIVE DAYS LATER (B)(6), THE CUSTOMER DECEASED.THE CAUSE OF DEATH CANNOT BE DETERMINED AS THE AC-3038, BUT IT COULD BE ONE OF THE FACTORS CAUSED THE DEATH. ACCORDING TO THE DOCTOR, IT IS A CONTRAINDICATION TO STOP A HEART RIGHT AFTER BEING TRANSPLANTED. HOWEVER, IN THIS CASE, DUE TO THE CUT OFF THE SUTURE THREAD, THERE WAS NO CHOICE OTHER THAN STOPPING THE HEART, WHICH WAS TOO MUCH STRAIN ON THE DONOR HEART. THE ANASTOMOSIS WAS DONE VERTICALLY, BUT IT IS POSSIBLE THAT THE CUSTOMER ACTUATED THE CUTTER AT AN ANGLE AT THE POINT OF 20MM AWAY FROM THE ANASTOMOSIS SITE.
N
Patient 1
(B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOT 25123187 THE ONLY LOT SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT DATE. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY.
D
Patient 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ON (B)(6) 2016, AFTER THE HEART TRANSPLANT, THE CUSTOMER USED THE AORTIC CUTTER (AC-3038) TO USE A HEARTSTRING III AT THE POINT OF 20MM AWAY FROM THE AORTA END-TO-END ANASTOMOSIS SITE AT THE DONOR SIDE, AND RIGHT AFTER, MASSIVE BLEEDING OCCURRED WITH UNKNOWN CAUSE. THE CUSTOMER TRIED TO STOP BLEEDING AND FOUND THAT THE SUTURE THREAD (PRONOVA4.0) USED FOR THE ANASTOMOSIS WAS CUT OFF AND THE AORTA WAS TORN. DUE TO THIS DAMAGE, THE CUSTOMER SWITCHED TO ON-PUMP, CLAMPED THE AORTA AND RE-ANASTOMOSED THE SITE. THEN, BLEEDING STOPPED. MORE THAN 20-UNIT BLOOD TRANSFUSION WAS PROVIDED AT THE OXYGENATOR SIDE. BEFORE USING THE AC-3038 CUTTER, THE CUSTOMER CHECKED THE AORTIC DIAMETER MORE THAN 25MM (THE ACTUAL MEASUREMENT WAS 30-35MM) AND THE BLOOD PRESSURE OF 50-55MMHG. AS THE PROCEDURE WAS SWITCHED FROM CABG TO ON-PUMP, THE CUSTOMER FINISHED THE SURGERY WITHOUT USING THE HEARTSTRING III. FIVE DAYS LATER ((B)(6)), THE CUSTOMER DECEASED.THE CAUSE OF DEATH CANNOT BE DETERMINED AS THE AC-3038, BUT IT COULD BE ONE OF THE FACTORS CAUSED THE DEATH. ACCORDING TO THE DOCTOR, IT IS A CONTRAINDICATION TO STOP A HEART RIGHT AFTER BEING TRANSPLANTED. HOWEVER, IN THIS CASE, DUE TO THE CUT OFF THE SUTURE THREAD, THERE WAS NO CHOICE OTHER THAN STOPPING THE HEART, WHICH WAS TOO MUCH STRAIN ON THE DONOR HEART. THE ANASTOMOSIS WAS DONE VERTICALLY, BUT IT IS POSSIBLE THAT THE CUSTOMER ACTUATED THE CUTTER AT AN ANGLE AT THE POINT OF 20MM AWAY FROM THE ANASTOMOSIS SITE.