INTERJECT¿
Report
- Report Number
- 3005099803-2013-01055
- Event Type
- Malfunction
- Date Received
- February 20, 2013
- Date of Event
- February 4, 2013
- Report Date
- February 4, 2013
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- FCG
- PMA / PMN Number
- K012864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(6). (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. THE NEEDLE WAS PRESENT AND ATTACHED. THE NEEDLE WAS RETRACTED WHEN RECEIVED. NO KINKS WERE FOUND ON THE OUTER SHEATH. THE HANDLE WAS COVERED WITH SMUDGES OF BLACK RESIDUE A FUNCTIONAL EVALUATION WAS PERFORMED AND THE NEEDLE EXTENDED AND RETRACTED AS INTENDED. THE INNER HUB AND SHEATH WAS REMOVED FROM THE OUTER HUB AND SHEATH; THE INNER SHEATH MOVED FREELY THROUGH THE OUTER DURING REMOVAL. THE INNER SHEATH HAD NO KINK. THE INNER SHEATH WAS FILLED WITH WHAT APPEARED TO BE A BLACK SCLEROSING AGENT ALL THROUGHOUT. THE DEVICE WAS TESTED TO IDENTIFY IF THE LUMEN WAS OCCLUDED. A SYRINGE FILLED WITH AIR WAS ATTACHED TO THE INNER HUB AND COMPRESSED. WHEN THE SYRINGE WAS COMPRESSED RESISTANCE WAS FELT CONFIRMING THAT THE DEVICE WAS OCCLUDED. DURING THE COMPRESSION, THERE WAS NO MOVEMENT OF THE BLACK SCLEROSING AGENT IN THE INNER SHEATH. THE INNER SHEATH WAS CUT JUST PROXIMAL TO THE NEEDLE SO THAT THE SHEATH AND NEEDLE COULD BE TESTED SEPARATELY. THE INNER SHEATH WAS COMPLETELY BLOCKED WITH THE BLACK SCLEROSING AGENT. THE SYRINGE WAS ONCE AGAIN FILLED WITH AIR, AND ATTACHED TO THE INNER HUB AND COMPRESSED. THE SYRINGE COULD NOT BE COMPRESSED; RESISTANCE WAS ENCOUNTERED. NEXT, A 0.009' PIN GAUGE WAS INSERTED INTO THROUGH THE NEEDLE INTO THE PROXIMAL END OF THE NEEDLE. THE PIN GAUGE WAS PUSHED INTO THE INNER DIAMETER OF THE NEEDLE, BUT IT COULD NOT EXIT ON THE OPPOSITE SIDE DUE TO THE BLOCKAGE IN THE NEEDLE. MOST LIKELY, THE BLACK SCLEROSING AGENT LIMITED THE PERFORMANCE OF THE NEEDLE DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE CONTRAST WAS NOT ABLE TO PASS THROUGH THE DEVICE. NO LEAKS WERE NOTED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE CONTRAST WAS NOT ABLE TO PASS THROUGH THE DEVICE. NO LEAKS WERE NOTED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73766 | INTERJECT¿ | KIT, NEEDLE, BIOPSY | FCG | BOSTON SCIENTIFIC - SPENCER | M00518361 | 15548770 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |