N
Patient 1
MAUDE MDR 5624471
- MDR report key
- 5624471
- Report number
- 5624471
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-03-29
- Date received
- 2016-05-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CRE | DILATOR, ESOPHAGEAL | BOSTON SCIENTIFIC CORPORATION | KCF | M00558380 | 18884819 | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-05-03 | 0 |
Event Narratives#
D
Patient 1
THE FIRST BALLOON DILATOR (LOT# 18884819) THAT WAS USED DID NOT GO ALL THE WAY THROUGH THE BIOPSY CHANNEL. IT WAS TRIED TWICE WITH NO SUCCESS. THE BALLOON CATHETER WOULD GET JAMMED/STUCK IN THE SCOPE. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS USED TO DILATE ESOPHAGUS. THE SECOND BALLOON CATHETER (LOT# 18846982) WOULD NOT DEFLATE 100% FOR IT TO BE REMOVED SAFELY THROUGH THE SCOPE. THE SCOPE HAD TO BE REMOVED FROM THE PATIENT AND THE BALLOON PORTION OF THE CATHETER WAS CUT/SEPARATED FROM THE REST OF THE CATHETER. THE REMAINING PART OF THE BALLOON CATHETER WAS SAFELY REMOVED FROM SCOPE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A NEW CATHETER WITH NO COMPLICATIONS TO THE PATIENT. MANUFACTURER RESPONSE FOR ESOPHAGEAL BALLOON CATHETER, CRE ESOPHAGEAL FIXED WIRE 18-20 (PER SITE REPORTER): SENT 2 REPLACEMENTS. OBTAINED INFORMATION FOR THEIR REPORT.