HALO SINGLE LOOP SNARE KIT 6F, 15MM X 120CM
Received Mar 13, 2023 · Event occurred Feb 6, 2023
Report 0001625425-2023-00999 · MDR key 16530875
Device
Generic name
Halo
Manufacturer
Argon Medical DevicesModel number
383615120Catalog number
383615120
Lot number
11438729
Product problems
- Peeled/Delaminated
- Material Separation
- Separation Problem
- Peeled/Delaminated
- Material Separation
- Separation Problem
Patient
Unknown
- Foreign Body In Patient
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Foreign Body In Patient
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO DEVIATIONS OR NON-CONFORMANCES WERE FOUND. ONE USED SAMPLE WAS SENT TO ARGON FROM THE CUSTOMER. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED PRODUCT. THE VISUAL INSPECTION DETERMINED THAT THE RADIOPAQUE BAND WAS NOT PRESENT ON THE CATHETER. SINCE THIS IS THE FIRST COMPLAINT WITH THIS ISSUE WITH THIS PART AND LOT NUMBER, THIS WILL BE TREATED AS AN ISOLATED OCCURRENCE.
Description of Event or Problem
IT WAS REPORTED THAT DR. (B)(6) HAD SNARED A PORT AND CATHETER, THEN TRIED TO ADVANCE TO PORT WITH THE SNARE AND THE RADIOPAQUE MARKER BAND CAME OFF THE CATHETER. IT WAS RETRIEVED AND THE ENTIRE UNIT IS ABLE TO BE SENT BACK.
Description of Event or Problem
IT WAS REPORTED THAT DR. GUAN HAD SNARED A PORT AND CATHETER, THEN TRIED TO ADVANCE TO PORT WITH THE SNARE AND THE RADIOPAQUE MARKER BAND CAME OFF THE CATHETER. IT WAS RETRIEVED AND THE ENTIRE UNIT IS ABLE TO BE SENT BACK.
Additional Manufacturer Narrative
THE SAMPLE IS INDICATED AS RETURNED. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN REVIEWED.
Additional Manufacturer Narrative
THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.
Description of Event or Problem
IT WAS REPORTED THAT DR. (B)(6) HAD SNARED A PORT AND CATHETER, THEN TRIED TO ADVANCE TO PORT WITH THE SNARE AND THE RADIOPAQUE MARKER BAND CAME OFF THE CATHETER. IT WAS RETRIEVED AND THE ENTIRE UNIT IS ABLE TO BE SENT BACK.