FGE CATHETER, BILIARY, DIAGNOSTIC
Report
- Report Number
- 1820334-2024-00025
- Event Type
- Malfunction
- Date Received
- January 3, 2024
- Date of Event
- December 13, 2023
- Report Date
- March 14, 2024
- Manufacturer
- COOK INC
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT THE SUTURE OF AN UNKNOWN 12.0 FRENCH PIGTAIL DRAINAGE CATHETER BROKE. THE CATHETER WAS PLACED ON (B)(6) 2023. LATER DURING REMOVAL, THE SUTURE STRING WAS RELEASED AND UNLOOPED FROM THE LOCKING MECHANISM. HOWEVER, RESISTANCE WAS EXPERIENCED DURING ATTEMPTED REMOVAL OF THE CATHETER. IT WAS OBSERVED THAT SUTURE TENSION REMAINED AT THE CATHETER TIP DESPITE RELEASE FROM THE LOCKING MECHANISM. THE CATHETER WAS PULLED TAUT, AND A SNAP WAS HEARD. THE CATHETER WAS REMOVED FROM THE PATIENT; HOWEVER, THE SUTURE REMAINED IN THE PATIENT AND WAS PULLED OUT AFTER THE CATHETER. THE PATIENT COMPLAINED OF PAIN DUE TO THE EVENT. NO ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF DOCUMENTATION INCLUDING THE QUALITY CONTROL PROCEDURES, INSTRUCTION FOR USE (IFU), AND SPECIFICATIONS OF THE COMPLAINT DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICE. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER OVER THREE YEARS PRIOR TO THE DATE (13DEC2020 ¿ 13DEC2023) OF THE INCIDENT. DURING THE EXPANDED SEARCH, COOK MEDICAL IDENTIFIED THE MULTIPURPOSE DRAINAGE CATHETER AS THE MOST PROBABLE DEVICE, BASED ON THE AMOUNT OF SALES; HOWEVER, THE COMPLAINT LOT WAS UNABLE TO IDENTIFIED. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. BASED ON THIS INFORMATION, THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU [T_MULTI2_REV1] PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: "PRECAUTIONS: -WHEN INSERTING A STIFFENING CANNULA INTO A CATHETER WITH RETENTION SUTURE, HOLD SUTURE DURING CANNULA INSERTION TO AVOID BUNCHING OR TANGLING OF SUTURE. -A TFE-COATED WIRE GUIDE MUST BE USED WITH ULTRATHANE CATHETERS. INSTRUCTIONS FOR USE: UNLOCKING CATHETER LOOP FOR MAC-LOC LOCKING LOOP MECHANISM: A. WHILE STABILIZING THE MAC-LOC CATHETER HUB ASSEMBLY WITH ONE HAND, POSITION A SMALL, BLUNT OBJECT (APPROXIMATELY THE SHAPE AND SIZE OF A BALL POINT PEN OR SMALL FORCEPS) INTO THE MAC-LOC RELEASE NOTCH. B. PRY UPWARD UNTIL THE LOCKING CAM LEVER IS FREE. (FIG. 4) HOW SUPPLIED UPON REMOVAL ROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE EVENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THE IDENTITY OF THE DEVICE IS CURRENTLY UNKNOWN. THE PRODUCT CODE AND 510(K) PROVIDED ARE BASED ON THE LIMITED PRODUCT INFORMATION AVAILABLE AT THIS TIME. D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D2B - PROCODE: ADDITIONAL PRODUCT CODES: GBO, LJE. E1- CUSTOMER (PERSON): PHONE: (B)(6). E3- OCCUPATION: NURSING EDUCATOR; ACTING CLINICAL NURSE EDUCATOR WARD 8D. G4 ¿ PMA/510(K) #: K173035. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B5, D9, H3 CORRECTION: H6 (ANNEX E), H6 (ANNEX F) THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IT WAS REPORTED THAT THE SUTURE OF AN UNKNOWN 12.0 FRENCH PIGTAIL DRAINAGE CATHETER BROKE. THE CATHETER WAS PLACED ON (B)(6) 2023. LATER DURING REMOVAL, THE SUTURE STRING WAS RELEASED AND UNLOOPED FROM THE LOCKING MECHANISM. HOWEVER, RESISTANCE WAS EXPERIENCED DURING ATTEMPTED REMOVAL OF THE CATHETER. IT WAS OBSERVED THAT SUTURE TENSION REMAINED AT THE CATHETER TIP DESPITE RELEASE FROM THE LOCKING MECHANISM. THE CATHETER WAS PULLED TAUT, AND A SNAP WAS HEARD. THE CATHETER WAS REMOVED FROM THE PATIENT; HOWEVER, THE SUTURE REMAINED IN THE PATIENT AND WAS PULLED OUT AFTER THE CATHETER. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
ADDITIONAL INFORMATION WAS PROVIDED ON 28JAN2024. THE EXTERNAL SUTURE HAD ALREADY BEEN REMOVED PRIOR TO ATTEMPT OF REMOVAL OF THE CATHETER. THE CATHETER HAD TO BE PULLED TAUGHT WHICH SNAPPED THE CATHETER'S SUTURE STRING. THIS ALLOWED THE TENSION TO BE RELEASED, AND THE CATHETER TO BE REMOVED. THE PATIENT COMPLAINED OF PAIN DUE TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 761022 | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |