SPYSCOPE DS II ACCESS & DELIVERY CATHETER
Report
- Report Number
- 3005099803-2024-03256
- Event Type
- Death
- Date Received
- July 12, 2024
- Date of Event
- June 17, 2024
- Report Date
- September 20, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FBN
- PMA / PMN Number
- K183636
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H6: IMDRF PATIENT CODE E0602 CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF PATIENT WAS TRANSFERRED TO INTENSIVE CARE. IMDRF IMPACT CODE F2306 CAPTURES THE REPORTABLE EVENT OF CARDIOPULMONARY RESUSCITATION.
BLOCKS B2 (OUTCOMES ATTRIB TO ADV EVENT AND DATE OF DEATH), B5, H6 (PATIENT CODES AND IMPACT CODES) HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON JULY 16, 2024. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H1 (TYPE OF REPORTABLE EVENT) HAVE BEEN UPDATED WITH A CORRECTION NOTICED ON SEPTEMBER 20, 2024. BLOCK H6: IMDRF PATIENT CODE E0602 CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST. IMDRF PATIENT CODE E050301 CAPTURES THE REPORTABLE EVENT OF AIR EMBOLISM. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF PATIENT WAS TRANSFERRED TO INTENSIVE CARE. IMDRF IMPACT CODE F2306 CAPTURES THE REPORTABLE EVENT OF CARDIOPULMONARY RESUSCITATION. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT'S DEATH.
BLOCKS B2 (OUTCOMES ATTRIB TO ADV EVENT AND DATE OF DEATH), B5, H6 (PATIENT CODES AND IMPACT CODES) HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON JULY 16, 2024. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H6: IMDRF PATIENT CODE E0602 CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST. IMDRF PATIENT CODE E050301 CAPTURES THE REPORTABLE EVENT OF AIR EMBOLISM. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF PATIENT WAS TRANSFERRED TO INTENSIVE CARE. IMDRF IMPACT CODE F2306 CAPTURES THE REPORTABLE EVENT OF CARDIOPULMONARY RESUSCITATION. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT'S DEATH.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPYSCOPE DS II ACCESS & DELIVERY CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOPOGRAPHY (ERCP) PERFORMED FOR DUCTAL CLEARANCE IN THE COMMON BILE DUCT ON (B)(6) 2024. THE PHYSICIAN ACCESSED THE SITE AND TOOK A CHOLANGIOGRAM. THEY THEN CANNULATED WITH A SPYSCOPE AND CONFIRMED DUCTAL CLEARANCE. THE PHYSICIAN THEN REMOVED THE SCOPE. AFTER THE SCOPE WAS REMOVED, THE PATIENT CODED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT AND END-OF-LIFE CARE. THERE IS NO PERFORMANCE ALLEGATION AGAINST THE SPYSCOPE USED IN THIS CASE. THE PATIENTS CURRENT CONDITION IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPYGLASS DIRECT VISUALIZATION PROBE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOPOGRAPHY (ERCP) SPYGLASS PROCEDURE IN THE COMMON BILE DUCT FOR THE TREATMENT OF DUCTAL CLEARANCE ON (B)(6) 2024. IT WAS REPORTED THAT THE DR DID NOT PASS ANY DEVICES DOWN THE CHANNEL WHEN HE TOOK THE SCOPE OUT, THE PATIENT CODED AND NEEDS CPR. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPYSCOPE DS II ACCESS & DELIVERY CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED FOR DUCTAL CLEARANCE IN THE COMMON BILE DUCT ON (B)(6) 2024. THE PHYSICIAN ACCESSED THE SITE AND TOOK A CHOLANGIOGRAM. THEY THEN CANNULATED WITH A SPYSCOPE AND CONFIRMED DUCTAL CLEARANCE. THE PHYSICIAN THEN REMOVED THE SCOPE. AFTER THE SCOPE WAS REMOVED, THE PATIENT CODED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT AND END-OF-LIFE CARE. THERE IS NO PERFORMANCE ALLEGATION AGAINST THE SPYSCOPE USED IN THIS CASE. THE PATIENT'S CURRENT CONDITION IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON JULY 16, 2024: THE PATIENT DIED ON (B)(6) 2024. REPORTEDLY, "THERE WAS THOUGHT OF AIR EMBOLISM. PATIENT REPORTED THAT SHE HAD A BLOOD CLOT."
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPYSCOPE DS II ACCESS & DELIVERY CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED FOR DUCTAL CLEARANCE IN THE COMMON BILE DUCT ON (B)(6) 2024. THE PHYSICIAN ACCESSED THE SITE AND TOOK A CHOLANGIOGRAM. THEY THEN CANNULATED WITH A SPYSCOPE AND CONFIRMED DUCTAL CLEARANCE. THE PHYSICIAN THEN REMOVED THE SCOPE. AFTER THE SCOPE WAS REMOVED, THE PATIENT CODED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT AND END-OF-LIFE CARE. THERE IS NO PERFORMANCE ALLEGATION AGAINST THE SPYSCOPE USED IN THIS CASE. THE PATIENT'S CURRENT CONDITION IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON JULY 16, 2024. THE PATIENT DIED ON (B)(6) 2024. REPORTEDLY, "THERE WAS THOUGHT OF AIR EMBOLISM. PATIENT REPORTED THAT SHE HAD A BLOOD CLOT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2426752 | SPYSCOPE DS II ACCESS & DELIVERY CATHETER | CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FBN | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Hospitalization| D| R| L |