FDA Adverse Event
Injury
Summary report: N
EXPECT PULMONARY
MDR report key: 16108029
·
Received January 5, 2023
Report
- Report Number
- 3005099803-2022-07608
- Event Type
- Injury
- Date Received
- January 5, 2023
- Date of Event
- December 14, 2022
- Report Date
- January 5, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- EOQ
- UDI-DI
- 08714729861409
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PREMARKET / 510(K) #: K163248 & K151895.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A LITTLE FRAGMENT (4MM) FROM THE NEEDLE HAS DETACHED. IT IS IDENTICAL TO THE STYLET OR 'GUIDANCE' OF THE NEEDLE. THE DETACHED TIP WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1724105 | EXPECT PULMONARY | BRONCHOSCOPE (FLEXIBLE OR RIGID) | EOQ | BOSTON SCIENTIFIC CORPORATION | M00558220 | 0030375677 | 08714729861409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |