INTERJECT¿
Report
- Report Number
- 3005099803-2012-02856
- Event Type
- Malfunction
- Date Received
- July 20, 2012
- Date of Event
- June 29, 2012
- Report Date
- June 29, 2012
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- FCG
- PMA / PMN Number
- K012864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- PHYSICIAN
Narratives
THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. 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.
EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT THE NEEDLE WAS BLOCKED/OCCLUDED. A VISUAL EVALUATION WAS PERFORMED; NO DAMAGE OR ANOMALIES WERE OBSERVED. A FUNCTIONAL EVALUATION WAS PERFORMED AND THE NEEDLE EXTENDED AND RETRACTED AS INTENDED. THE DEVICE WAS TESTED TO IDENTIFY IF THE LUMEN WAS OCCLUDED. A SYRINGE FILLED WITH AIR WAS ATTACHED TO THE INNER HUB AND COMPRESSED; THE SYRINGE WAS NOT ABLE TO BE COMPRESSED. A PIN GAUGE WAS INSERTED THROUGH THE NEEDLE INTO THE PROXIMAL END OF THE NEEDLE. SOME RESISTANCE WAS MET, AND A SMALL PIECE OF SILICONE WAS EXTRACTED FROM THE INNER DIAMETER. THIS SUBSTANCE IS LIKELY 'MDX', A SILICONE BASED LUBRICANT APPLIED TO THE OUTSIDE OF THE INNER SHEATH DURING MANUFACTURING. THIS IS RESIDUAL FROM THE FABRICATION PROCESS, AND DOES NOT APPEAR TO BE A FOREIGN CONTAMINANT. IN ADDITION, MDX WAS EVALUATED FOR BIOCOMPATIBILITY AND MET BIOCOMPATIBILITY REQUIREMENTS. 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 AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PHYSICIAN INJECTED THE MEDICINE INTO THE DEVICE, AND FOUND THAT THE NEEDLE WAS BLOCKED. NO DAMAGED WAS NOTED TO THE DEVICE, OR DEVICE PACKAGING. ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 STABLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PHYSICIAN INJECTED THE MEDICINE INTO THE DEVICE, AND FOUND THAT THE NEEDLE WAS BLOCKED. NO DAMAGED WAS NOTED TO THE DEVICE, OR DEVICE PACKAGING. ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 STABLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PHYSICIAN INJECTED THE MEDICINE INTO THE DEVICE, AND FOUND THAT THE NEEDLE WAS BLOCKED. NO DAMAGED WAS NOTED TO THE DEVICE, OR DEVICE PACKAGING. ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERJECT¿ | KIT, NEEDLE, BIOPSY | FCG | BOSTON SCIENTIFIC - SPENCER | M00518311 | 14917010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |