EXPECT PULMONARY
Report
- Report Number
- 3005099803-2022-03428
- Event Type
- Malfunction
- Date Received
- June 24, 2022
- Date of Event
- June 8, 2022
- Report Date
- September 2, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- EOQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. PREMARKET / 510(K) #: K163248 & K151895. (B)(4) CAPTURES THE REPORTABLE EVENT OF FOREIGN MATERIAL PRESENT IN DEVICE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL EMDR WILL BE FILED.
BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G4: PREMARKET / 510(K) #: K163248 & K151895. BLOCK H6: DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATERIAL PRESENT IN DEVICE. BLOCK H10: INVESTIGATION RESULTS THE RETURNED EXPECT PULMONARY NEEDLE WAS ANALYZED, AND A VISUAL EVALUATION WAS PERFORMED SHOWING NO DAMAGES OR ADDITIONAL DEFECTS. THE FOREIGN MATERIAL WAS NOT RETURNED WITH THE DEVICE. PHOTOS OF THE FOREIGN MATERIAL WERE PROVIDED BY THE CUSTOMER, HOWEVER IT WAS NOT POSSIBLE TO DETERMINE WHAT THE FOREIGN MATERIAL WAS. NO OTHER ISSUES WERE NOTED. BASED ON ALL AVAILABLE INFORMATION AND THE CONDITION OF THE RETURNED DEVICE, IT IS POSSIBLE THAT MANIPULATION, OR EQUIPMENT USED COULD HAVE AFFECTED THE PROCEDURE CAUSING THE REPORTED COMPLAINT. NO SIGNS OR REMNANTS OF FOREIGN MATERIAL WERE FOUND INSIDE THE DEVICE, AND NO OTHER ATTACHMENTS WERE RECEIVED IN WITH THE DEVICE. THE INVESTIGATION CONCLUDED THE MOST PROBABLE ROOT CAUSE IS CAUSE NOT ESTABLISHED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, A SHIP HISTORY REVIEW WAS PERFORMED TO IDENTIFY THE MOST PROBABLE LOTS, AND A DHR REVIEW ON THE MOST PROBABLE LOTS DID NOT IDENTIFY ANY DEVIATIONS WITHIN MANUFACTURING/SERVICE PROCESSES THAT COULD HAVE CONTRIBUTED TO THE EVENT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LUNG DURING A PULMONARY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, ON THE SECOND PUNCTURE, A SPLINTER-LIKE OBJECT WAS VISIBLE IN THE LUNG. REPORTEDLY, THE SPLINTER CAME FROM THE EXPECT PULMONARY NEEDLE. THE SPLINTER WAS WASHED AWAY AFTER ANESTHESIA AND LATER FOUND IN THE WASH. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LUNG DURING A PULMONARY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, ON THE SECOND PUNCTURE, A SPLINTER-LIKE OBJECT WAS VISIBLE IN THE LUNG. REPORTEDLY, THE SPLINTER CAME FROM THE EXPECT PULMONARY NEEDLE. THE SPLINTER WAS WASHED AWAY AFTER ANESTHESIA AND LATER FOUND IN THE WASH. 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 |
|---|---|---|---|---|---|---|---|
| 1171644 | EXPECT PULMONARY | BRONCHOSCOPE (FLEXIBLE OR RIGID) | EOQ | BOSTON SCIENTIFIC CORPORATION | M00558220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |