COLON DECOMPRESSION SET
Report
- Report Number
- 3001845648-2022-00747
- Event Type
- Malfunction
- Date Received
- November 7, 2022
- Report Date
- November 21, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FEG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # K171619. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K171619. DEVICE EVALUATION: THE CDSG-14-175 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW INCLUDING IFU REVIEW: AS THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION CDSG-14-175 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING IN RELATION TO POTENTIAL ADVERSE EVENTS ASSOCIATED WITH USE OF THIS DEVICE: ¿THOSE ASSOCIATED WITH COLON DECOMPRESSION INCLUDE, BUT ARE NOT LIMITED TO: CLOGGING OF THE TUBE, DISLODGEMENT OF THE COLON DECOMPRESSION TUBE/WIRE GUIDE, FEVER AND DISCOMFORT, HAEMORRHAGE, HYPOTENSION, INFECTION, MIGRATION, PAIN, PERFORATION, SEPSIS ." IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE "THIS DEVICE IS INTENDED FOR TREATMENT OF ACUTE NON-TOXIC MEGACOLON, PSEUDO-OBSTRUCTION (OGILVIE'S SYNDROME) AND COLONIC STRICTURES" AND ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. AS PER INFORMATION REPORTED IN THE PATIENT/EVENT INFO - NOTES SECTION, THERE IS NO ADDITIONAL MANUFACTURER QUESTIONS TO BE REQUESTED AS PER DIRECTION FROM COOK RESEARCH INSTITUTE MANAGEMENT. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE IT STATED INTENDED USE. IT WAS CONFIRMED THAT THAT THE USE OF CDSG DEVICE IN THE VOLVULUS IS OFF LABEL USE. THE MIGRATION THAT OCCURRED IS SECONDARY TO THE OFF-LABEL USE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE DECOMPRESSION TUBE WAS REPLACED AND THE PATIENT EXITED THE STUDY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
AS REPORTED TO CUSTOMER RELATIONS VIA CRI FORM - IN (B)(6) 2020, THE PATIENT HAD A DECOMPRESSION DEVICE IMPLANTED DUE TO VOLVULUS WITHOUT DIFFICULTY. THE PATIENT EXPERIENCED MIGRATION OF THE DECOMPRESSION TUBE 48 HOURS AFTER PLACEMENT. THE SITE HAS INDICATED THE EVENT WAS NOT RELATED TO THE COLON DECOMPRESSION TUBE OR STUDY PROCEDURE AND THERE WAS NO DEVICE DEFICIENCY. PER THE SITE, ¿THE TUBE MIGRATED OUT AFTER 48 HOURS, THEY WENT IN AND PLACED ANOTHER TUBE FOR THE PATIENT THE INDICATION WAS VOLVULUS¿. (IDENTIFIER/PRODUCT CODE DEVICE 2 -CDSG-14-175) UNS001 FINAL PMCF REPORT RECEIVED ON (B)(6) 2022 IT WAS CONFIRMED BY MEDICAL AFFAIRS THAT THE USE OF CDSG DEVICE IN THE VOLVULUS IS OFF LABEL USE FOR THIS DEVICE. AS PER THE IFU THAT ACCOMPANIES THIS DEVICE, INTENDED USE ¿THIS DEVICE IS UNTENDED FOR TREATMENT OF ACUTE NON-TOXIC MEGACOLON PSEUDO-OBSTRUCTION (OGILVIE¿S SYNDROME) AND COLONIC STRICTURES.
SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 21-NOV-2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2838272 | COLON DECOMPRESSION SET | FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION | FEG | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Male |