COLON DECOMPRESSION SET
Report
- Report Number
- 3001845648-2024-00074
- Event Type
- Injury
- Date Received
- February 27, 2024
- Date of Event
- February 1, 2024
- Report Date
- May 17, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FEG
- UDI-DI
- 00827002221819
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
510(K) # K171619. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL CDSG-14-175 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE CDSG-14-175 DEVICE OF LOT NUMBER C1815915 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: A REVIEW OF THE MANUFACTURING RECORDS FOR THE CDSG-14-75 DEVICE CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1815915. INSTRUCTIONS FOR USE AND LABEL: IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE (IFU0102), "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 (IFU0102) IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE. USE OF THE CDSG-14-175 DEVICE TO TREAT VOLVULUS IS CONSIDERED OFF-LABEL USE AS THE DEVICE IS NOT INDICATED IN THE IFU FOR TREATMENT OF THE VOLVULUS. ALTHOUGH THE SURGEON UNDID THE VOLVULUS USING THE COLONOSCOPE, THE CDSG COLON DECOMPRESSION TUBE WOULD NOT BE STRONG ENOUGH TO HOLD THE COLON IN PLACE AND PREVENT THE REFORMATION OF THE VOLVULUS OR THE DECOMPRESSION TUBE COULDN¿T BE PLACED INTO THE COLON IMMEDIATELY AFTER COLON BEING UNTWISTED BY SCOPE BECAUSE THE UNTWISTED COLON HASN¿T RECOVERED TO ITS NORMAL POSITION. BOTH OF WHICH WOULD HAVE CREATED THE DIFFICULTY WITH THE GUIDE WIRE AND CATHETER BECOMING STUCK IN THE DECOMPRESSION TUBE, ALL OF WHICH ARE CASCADING EFFECTS OF THE OFF-LABEL USE OF THE DEVICE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, GUIDE WIRE AND GUIDE CATHETER GETS STUCK IN DECOMPRESSION TUBE. CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENT WAS SENT TO SURGERY FOR A SCAN AND INTESTINAL RESECTION. THE PATIENT WAS HOSPITALIZED AND PER THE PHYSICIAN IT IS UNKNOWN FOR WHAT LENGTH OF TIME. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE. USE OF THE CDSG-14-175 DEVICE TO TREAT VOLVULUS IS CONSIDERED OFF-LABEL USE AS THE DEVICE IS NOT INDICATED IN THE IFU FOR TREATMENT OF THE VOLVULUS. ALTHOUGH THE SURGEON UNDID THE VOLVULUS USING THE COLONOSCOPE, THE CDSG COLON DECOMPRESSION TUBE WOULD NOT BE STRONG ENOUGH TO HOLD THE COLON IN PLACE AND PREVENT THE REFORMATION OF THE VOLVULUS OR THE DECOMPRESSION TUBE COULDN¿T BE PLACED INTO THE COLON IMMEDIATELY AFTER COLON BEING UNTWISTED BY SCOPE BECAUSE THE UNTWISTED COLON HASN¿T RECOVERED TO ITS NORMAL POSITION. BOTH OF WHICH WOULD HAVE CREATED THE DIFFICULTY WITH THE GUIDE WIRE AND CATHETER BECOMING STUCK IN THE DECOMPRESSION TUBE, ALL OF WHICH ARE CASCADING EFFECTS OF THE OFF-LABEL USE OF THE DEVICE.
PMA/510(K) # K171619 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
COMPLETE REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 17TH MAY 24.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A COLON DECOMPRESSION PROCEDURE IN WHICH THE COLON DECOMPRESSION SET, G22181, WAS USED. ONCE THE DEVICE WAS IN THE TARGET AREA IT WAS UNDER FLEURO CONTROL AT THE BEGINNING OF THE PROCEDURE. AT THE TIME OF PULLING OUT THE GUIDE WIRE AND GUIDE CATHETER AT THE SAME TIME IS IMPOSSIBLE. THE WIRE CAN BE REMOVED BUT THE GUIDE CATHETER GETS STUCK IN THE DECOMPRESSION TUBE. THE KIT WAS DISASSEMBLED AND REASSEMBLED AFTER LUBRICANT APPLIED BUT GUIDE CATHETER STAYS STUCK. AND THE GUIDE CATHETER CHANGED FORM, IT ELONGATED/STRETCHED OUT. IT WAS ALSO IMPOSSIBLE TO RE-INSERT THE WIRE AT THIS POINT AS WELL. THE PHYSICIAN STATED THE PROCEDURE WAS USELESS AND THE PATIENT WAS SENT TO SURGERY FOR A SCAN AND INTESTINAL RESECTION. THE PATIENT WAS HOSPITALIZED AND PER THE PHYSICIAN IT IS UNKNOWN FOR WHAT LENGTH OF TIME. ADDITIONAL INFORMATION PROVIDED PER DISTRICT MANAGERS FOLLOW UP PHONE DISCUSSION. TL 02FEB2024 THE SCOPE WAS A OLYMPUS COLONOSCOPE CF-HQ190L. ALSO, THE SURGEON UNDID THE VOLVULUS USING THE COLONOSCOPE BUT THEN THE COLON DECOMPRESSION DIDN'T WORK FOLLOWING THE UNTWISTING OF THE VOLVULUS WITH THE SCOPE. PATIENT OUTCOME: THE PHYSICIAN STATED THE PROCEDURE WAS USELESS AND THE PATIENT WAS SENT TO SURGERY FOR A SCAN AND INTESTINAL RESECTION. THE PATIENT WAS HOSPITALIZED AND PER THE PHYSICIAN IT IS UNKNOWN FOR WHAT LENGTH OF TIME. PATIENT/EVENT INFO - NOTES: 1.1 FOR ALL COMPLAINTS, ASK: 1.1.1 WAS THE DEVICE FLUSHED BEFORE USE? YES 1.1.2 WHAT WAS FLUSHED THROUGH THE DEVICE (WATER, SALINE, ETC.)? WATER AND LUBRICANT JELLY ¿ IF OTHER PLEASE SPECIFY 1.1.3 WAS LUBRICATION APPLIED TO THE DECOMPRESSION TUBE? YES 1.1.4 DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? NOT INFORMED 1.1.5 IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? THE PATIENT WAS SENT TO SURGERY FOR A SCAN AND INTESTINAL RESECTION. THE PATIENT WAS HOSPITALIZED AND PER THE PHYSICIAN IT IS UNKNOWN FOR WHAT LENGTH OF TIME. 1.1.6 PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. COLON 1.1.7 HOW EXPERIENCED WAS THE PHYSICIAN WITH USING THE CDSG? PER DM- NOT SURE HOW MANY TIMES BUT HAS USED THE DEVICE MANY TIMES 1.1.8 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? THE PATIENT WAS SENT TO SURGERY FOR A SCAN AND INTESTINAL RESECTION. THE PATIENT WAS HOSPITALIZED AND PER THE PHYSICIAN IT IS UNKNOWN FOR WHAT LENGTH OF TIME. 1.1.9 WHAT INTERVENTION (IF ANY) WAS REQUIRED? THE PATIENT WAS SENT TO SURGERY FOR A SCAN AND INTESTINAL RESECTION. THE PATIENT WAS HOSPITALIZED AND PER THE PHYSICIAN IT IS UNKNOWN FOR WHAT LENGTH OF TIME. 1.1.10 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME DAY- THE PATIENT WAS SENT TO SURGERY FOR A SCAN AND INTESTINAL RESECTION. THE PATIENT WAS HOSPITALIZED AND PER THE PHYSICIAN IT IS UNKNOWN FOR WHAT LENGTH OF TIME. 1.1.11 WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NONE NOTED- DEVICE IS NOT AVAILABLE TO RETURN. ¿ IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. 1.1.12 WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? THE SCOPE WAS A OLYMPUS COLONOSCOPE CF-HQ190L. 1.1.13 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DECOMPRESSION TUBE INTO POSITION? NOT INFORMED 1.1.14 IF RESISTANCE WAS ENCOUNTERED, WAS THE ENDOSCOPE WITHDRAWN A SHORT DISTANCE? NOT INFORMED 1.1.15 HOW OFTEN WAS THE DECOMPRESSION TUBE IRRIGATED? NOT INFORMED 1.1.16 DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? NO 1.1.17 HOW LONG WAS THE SET LEFT IN DWELLING? THIS WAS THE INITIAL PROCEDURE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116247 | COLON DECOMPRESSION SET | FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION | FEG | COOK IRELAND LTD | C1815915 | 00827002221819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |