CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE
Report
- Report Number
- 3005099803-2017-00162
- Event Type
- Injury
- Date Received
- January 31, 2017
- Date of Event
- January 3, 2017
- Report Date
- January 6, 2017
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- KOG
- PMA / PMN Number
- K140726
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
ADDITIONAL INFORMATION RECEIVED FEBRUARY 09, 2017 AND FEBRUARY 24, 2017.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL TRIAL. ON (B)(6) 2017, THE PATIENT WAS CONFIRMED OF HAVING A BARRETT'S ESOPHAGUS WITH VISIBLE ABNORMALITY. THE INDICATION FOR THE EMR PROCEDURE WAS HIGH-GRADE DYSPLASIA (HGD) OF FOCAL LESION. THE PATIENT DID NOT REQUIRE DISCONTINUATION OF ANTICOAGULANT THERAPY. ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. THE LESION WAS LOCATED 27 CM FROM THE DENTAL ARCH AT 6 O¿CLOCK. THE ESTIMATED DIAMETER OF THE LESION WAS 10 MM WITH A MAXIMUM CIRCUMFERENTIAL EXTENT OF 17%. THE LESION APPEARED PROTRUDED/SESSILE (0-IS). AFTER LESION DELINEATION, BUT PRIOR TO RESECTION, ENDOSCOPIC IMAGING WAS PERFORMED. THREE (3) RESECTIONS WERE PERFORMED AND IMMEDIATELY AFTER LESION RESECTION, ENDOSCOPIC IMAGING WAS PERFORMED. LIFTING WAS NOT PERFORMED. LESION WAS SUCCESSFULLY RESECTED IN A SINGLE PROCEDURE. ALL RESECTION SPECIMENS WERE RETRIEVED FOR HISTOPATHOLOGICAL EXAMINATION WITH THE CAPTIVATOR EMR CAP/SNARE. POST PROCEDURE, ON (B)(6) 2017, THE PATIENT EXPERIENCED BLEEDING. ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED AND PRESENTED WITH MELENA, NAUSEA AND DIZZINESS. THE BLEEDING, MELENA, NAUSEA AND DIZZINESS WERE CONSIDERED SERIOUS AND MILD, AND RELATED TO THE CAPTIVATOR EMR DEVICE AND PROCEDURE. THE PATIENT RECEIVED TWO (2) UNITS OF BLOOD VIA TRANSFUSION, WAS GIVEN PHENERGAN, AND TYLENOL PROPHYLACTICALLY. THE PATIENT REMAINS HOSPITALIZED AND THE EVENT WAS REPORTED TO BE UNRESOLVED. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 09, 2017: THE PATIENT WAS GIVEN TYLENOL TO TREAT THE POST PROCEDURAL PAIN THAT OCCURRED ON (B)(6) 2017. PHENERGAN WAS ALSO GIVEN TO THE PATIENT TO TREAT NAUSEA AND DIZZINESS; HOWEVER, THE PATIENT WAS NOT GIVEN ANY MEDICATION TO TREAT THE POST PROCEDURAL BLEEDING AND STILL REMAINS HOSPITALIZED. THE EVENT WAS REPORTED AS NOT RECOVERED/NOT RESOLVED. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 24, 2017: THE CAPTIVATOR¿ EMR PATHOLOGY KIT WAS NOT USED FOR HISTOLOGICAL PROCESSING OF RETRIEVED SAMPLES. RATHER, ONLY FORMALIN WAS USED TO PROCESS RETRIEVED RESECTION SPECIMENS. THREE SPECIMENS WERE RETRIEVED AND HISTOLOGY SHOWED LOW-GRADE DYSPLASIA (LGD). ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED FOR POST PROCEDURAL PAIN. ON (B)(6) 2017, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOR POST PROCEDURAL BLEEDING. ON (B)(6) 2017, IT WAS REPORTED THAT THE PATIENT'S POST PROCEDURAL PAIN, NAUSEA, DIZZINESS, MELENA, AND POST PROCEDURAL BLEEDING WERE RESOLVED. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 28, 2017: ON (B)(6) 2017, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOR MELENA, NAUSEA AND DIZZINESS, AND POST PROCEDURAL PAIN. ADDITIONAL INFORMATION RECEIVED ON MARCH 23, 2017: IT WAS NOTED THAT THE PATIENT WAS TAKING NSAIDS FOR THREE TO FOUR MONTHS FOR UNRELATED PAIN; THIS MOST LIKELY CONTRIBUTED TO THE BLEEDING. A CT OF THE ABDOMEN AND PELVIS WAS PERFORMED SHOWING NO SIGNS OF PERFORATION. THE PATIENT WAS FOUND TO BE SEPTIC WITH ACUTE BLOOD LOSS ANEMIA AND WAS GIVEN BROAD SPECTRUM ANTIBIOTICS WHICH WAS THEN NARROWED DOWN TO LAVEQUIN. THE PATIENT ALSO EXPERIENCED AN ONSET OF DIZZINESS ON (B)(6) 2017. THE EVENT WAS CONSIDERED SERIOUS AND MILD AND RELATED TO BOTH THE CAPTIVATOR¿ EMR DEVICE AND THE EMR PROCEDURE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2017 AND WAS DISCHARGED ON (B)(6) 2017. EVENT RESOLVED ON (B)(6) 2017.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 06, 2017 THAT A CAPTIVATOR ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL TRIAL. ON (B)(6) 2017, THE PATIENT WAS CONFIRMED OF HAVING A BARRETT'S ESOPHAGUS WITH VISIBLE ABNORMALITY. THE INDICATION FOR THE EMR PROCEDURE WAS HIGH-GRADE DYSPLASIA (HGD) OF FOCAL LESION. THE PATIENT DID NOT REQUIRE DISCONTINUATION OF ANTICOAGULANT THERAPY. ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. THE LESION WAS LOCATED 27 CM FROM THE DENTAL ARCH AT 6 O¿CLOCK. THE ESTIMATED DIAMETER OF THE LESION WAS 10 MM WITH A MAXIMUM CIRCUMFERENTIAL EXTENT OF 17%. THE LESION APPEARED PROTRUDED/SESSILE (0-IS). AFTER LESION DELINEATION, BUT PRIOR TO RESECTION, ENDOSCOPIC IMAGING WAS PERFORMED. THREE (3) RESECTIONS WERE PERFORMED AND IMMEDIATELY AFTER LESION RESECTION, ENDOSCOPIC IMAGING WAS PERFORMED. LIFTING WAS NOT PERFORMED. LESION WAS SUCCESSFULLY RESECTED IN A SINGLE PROCEDURE. ALL RESECTION SPECIMENS WERE RETRIEVED FOR HISTOPATHOLOGICAL EXAMINATION WITH THE CAPTIVATOR EMR CAP/SNARE. POST PROCEDURE, ON (B)(6) 2017, THE PATIENT EXPERIENCED BLEEDING. ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED AND PRESENTED WITH MELENA, NAUSEA AND DIZZINESS. THE BLEEDING, MELENA, NAUSEA AND DIZZINESS WERE CONSIDERED SERIOUS AND MILD, AND RELATED TO THE CAPTIVATOR EMR DEVICE AND PROCEDURE. THE PATIENT RECEIVED TWO (2) UNITS OF BLOOD VIA TRANSFUSION, WAS GIVEN PHENERGAN, AND TYLENOL PROPHYLACTICALLY. THE PATIENT REMAINS HOSPITALIZED AND THE EVENT WAS REPORTED TO BE UNRESOLVED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE WAS USED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL TRIAL. ON (B)(6) 2017, THE PATIENT WAS CONFIRMED OF HAVING A BARRETT'S ESOPHAGUS WITH VISIBLE ABNORMALITY. THE INDICATION FOR THE EMR PROCEDURE WAS HIGH-GRADE DYSPLASIA (HGD) OF FOCAL LESION. THE PATIENT DID NOT REQUIRE DISCONTINUATION OF ANTICOAGULANT THERAPY. ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. THE LESION WAS LOCATED 27 CM FROM THE DENTAL ARCH AT 6 O¿CLOCK. THE ESTIMATED DIAMETER OF THE LESION WAS 10 MM WITH A MAXIMUM CIRCUMFERENTIAL EXTENT OF 17%. THE LESION APPEARED PROTRUDED/SESSILE (0-IS). AFTER LESION DELINEATION, BUT PRIOR TO RESECTION, ENDOSCOPIC IMAGING WAS PERFORMED. THREE (3) RESECTIONS WERE PERFORMED AND IMMEDIATELY AFTER LESION RESECTION, ENDOSCOPIC IMAGING WAS PERFORMED. LIFTING WAS NOT PERFORMED. LESION WAS SUCCESSFULLY RESECTED IN A SINGLE PROCEDURE. ALL RESECTION SPECIMENS WERE RETRIEVED FOR HISTOPATHOLOGICAL EXAMINATION WITH THE CAPTIVATOR EMR CAP/SNARE. POST PROCEDURE, ON (B)(6) 2017, THE PATIENT EXPERIENCED BLEEDING. ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED AND PRESENTED WITH MELENA, NAUSEA AND DIZZINESS. THE BLEEDING, MELENA, NAUSEA AND DIZZINESS WERE CONSIDERED SERIOUS AND MILD, AND RELATED TO THE CAPTIVATOR EMR DEVICE AND PROCEDURE. THE PATIENT RECEIVED TWO (2) UNITS OF BLOOD VIA TRANSFUSION, WAS GIVEN PHENERGAN, AND TYLENOL PROPHYLACTICALLY. THE PATIENT REMAINS HOSPITALIZED AND THE EVENT WAS REPORTED TO BE UNRESOLVED. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 09, 2017. THE PATIENT WAS GIVEN TYLENOL TO TREAT THE POST PROCEDURAL PAIN THAT OCCURRED ON (B)(6) 2017. PHENERGAN WAS ALSO GIVEN TO THE PATIENT TO TREAT NAUSEA AND DIZZINESS; HOWEVER, THE PATIENT WAS NOT GIVEN ANY MEDICATION TO TREAT THE POST PROCEDURAL BLEEDING AND STILL REMAINS HOSPITALIZED. THE EVENT WAS REPORTED AS NOT RECOVERED/NOT RESOLVED. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 24, 2017. THE CAPTIVATOR¿ EMR PATHOLOGY KIT WAS NOT USED FOR HISTOLOGICAL PROCESSING OF RETRIEVED SAMPLES. RATHER, ONLY FORMALIN WAS USED TO PROCESS RETRIEVED RESECTION SPECIMENS. THREE SPECIMENS WERE RETRIEVED AND HISTOLOGY SHOWED LOW-GRADE DYSPLASIA (LGD). ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED FOR POST PROCEDURAL PAIN. ON (B)(6) 2017, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOR POST PROCEDURAL BLEEDING. ON (B)(6) 2017, IT WAS REPORTED THAT THE PATIENT'S POST PROCEDURAL PAIN, NAUSEA, DIZZINESS, MELENA, AND POST PROCEDURAL BLEEDING WERE RESOLVED. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 28, 2017. ON (B)(6) 2017, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOR MELENA, NAUSEA AND DIZZINESS, AND POST PROCEDURAL PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74263 | CAPTIVATOR¿ ENDOSCOPIC MUCOSAL RESECTION DEVICE | ENDOSCOPE AND/OR ACCESSORIES | KOG | BOSTON SCIENTIFIC - SPENCER | M00561600 | 0019273460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |