EXPECT PULMONARY OLYMPUS 22GA - BOX 5
Report
- Report Number
- 3005099803-2023-00206
- Event Type
- Malfunction
- Date Received
- February 13, 2023
- Date of Event
- January 19, 2023
- Report Date
- September 19, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- EOQ
- UDI-DI
- 08714729861430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PREMARKET / 510(K) #: K163248, K151895. DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF A FILAMENT OF ABOUT 3MM CAME OUT OF THE NEEDLE.
BLOCK G4: PREMARKET / 510(K) #: K163248, K151895. BLOCK H6: DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF A FILAMENT OF ABOUT 3MM CAME OUT OF THE NEEDLE. BLOCK H10: INVESTIGATION RESULTS ONE EXPECT PULMONARY NEEDLE WAS RECEIVED FOR ANALYSIS, AND A VISUAL INSPECTION NOTED THAT THERE WAS NO DAMAGE TO THE DEVICE AND NO RESIDUE ON THE DEVICE. THE CUSTOMER ALSO PROVIDED A PHOTO SHOWING THE DISTAL TIP WITH A SMALL AMOUNT OF RESIDUE. ADDITIONALLY, A CONTAINER WAS ALSO RETURNED WITH THE DEVICE CONTAINING A RESIDUE SIMILAR TO THE RESIDUE SEEN IN THE PHOTO. BIO RAD ANALYSIS WAS PERFORMED, AND THE FOREIGN MATERIAL PRESENTED A MATCH GREATER THAN 80% TO THERMOPLASTIC MATERIALS LIKE POLYETHER ETHER KETONE (PEEK), A THERMOPLASTIC POLYMER. THE REPORTED EVENT OF "DEVICE FOREIGN MATERIAL PRESENT IN DEVICE'' IS CONFIRMED. FURTHER INVESTIGATION FOUND THAT THE DEVICE SHEATH ALSO MATCHES WITH PEEK. BASED ON THE INFORMATION AVAILABLE, THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL.
BLOCK G4: PREMARKET / 510(K) #: K163248, K151895. BLOCK H6: DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF A FILAMENT OF ABOUT 3MM CAME OUT OF THE NEEDLE. BLOCK H10: INVESTIGATION RESULTS ONE EXPECT PULMONARY NEEDLE WAS RECEIVED FOR ANALYSIS. MEDIA ANALYSIS OF THE RETURNED DEVICE FOUND NO SIGNS OF A POSSIBLE FOREIGN MATERIAL ON THE NEEDLE. HOWEVER, THE CUSTOMER PROVIDED A CONTAINER THAT SEEMS TO HAVE A RESIDUE AND IT WAS FOUND THAT THE FOREIGN MATERIAL PRESENTED A MATCH TO THERMOPLASTIC MATERIALS. THE REPORTED EVENT OF "DEVICE FOREIGN MATERIAL PRESENT IN DEVICE'' IS CONFIRMED. THE CONCLUSION WAS SELECTED BECAUSE IT WAS REPORTED THAT "THEY TESTED THE NEEDLE OUTSIDE THE PATIENT BEFORE THE PROCEDURE (TO PREVENT IT TO HAPPEN INSIDE THE PATIENT), BY EXTENDING AND RETRACTING THE NEEDLE A FEW TIMES, AND A FILAMENT OF ABOUT 3 MM CAME OUT OF THE NEEDLE", AND AFTER THE PRODUCT ANALYSIS IT WAS FOUND THAT THE CUSTOMER PROVIDED A CONTAINER THAT SEEMS TO HAVE A RESIDUE IN IT, SIMILAR TO THE ONE IN THE PICTURE PROVIDED BY THE CUSTOMER. THEREFORE, IT IS NOT CLEAR WHERE THE FOREIGN MATERIAL CAME FROM, AND THE CONCLUSION CODE OF CONCLUSION NOT YET AVAILABLE WAS SELECTED AS THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS PROBLEM. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE TRACHEOBRONCHIAL TREE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PREPARATION, THEY TESTED THE NEEDLE OUTSIDE THE PATIENT BY EXTENDING AND RETRACTING THE NEEDLE A FEW TIMES, AND A FILAMENT OF ABOUT 3MM CAME OUT OF THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. 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 TRACHEOBRONCHIAL TREE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PREPARATION, THEY TESTED THE NEEDLE OUTSIDE THE PATIENT BY EXTENDING AND RETRACTING THE NEEDLE A FEW TIMES, AND A FILAMENT OF ABOUT 3MM CAME OUT OF THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. 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 TRACHEOBRONCHIAL TREE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PREPARATION, THEY TESTED THE NEEDLE OUTSIDE THE PATIENT BY EXTENDING AND RETRACTING THE NEEDLE A FEW TIMES, AND A FILAMENT OF ABOUT 3MM CAME OUT OF THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1654086 | EXPECT PULMONARY OLYMPUS 22GA - BOX 5 | BRONCHOSCOPE (FLEXIBLE OR RIGID) | EOQ | BOSTON SCIENTIFIC CORPORATION | M00558221 | 0030421184 | 08714729861430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |