ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
Report
- Report Number
- 1820334-2025-00987
- Event Type
- Injury
- Date Received
- August 13, 2025
- Date of Event
- August 3, 2025
- Report Date
- January 13, 2026
- Manufacturer
- COOK INC
- Product Code
- FGE
- PMA / PMN Number
- K173035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
D2A- ADDITIONAL COMMON NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D2B- ADDITIONAL PRODUCT CODES: GBO; LJE. E3 - OCCUPATION: MSN, RN, CVAHP, CWOCN, NETWORK PROGRAM MANAGER NWN, VALUE ANALYSIS H3 - DEVICE EVALUATED BY MFG.? DEVICE EVALUATION ANTICIPATED BUT HAS NOT BEGUN. AWAITING DEVICE RETURN. 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.
INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT THE MAC-LOC HUB DETACHED FROM AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. THE DEVICE WAS PLACED ON (B)(6) 2025 AS A CHEST TUBE IN A PATIENT OF UNKNOWN AGE AND GENDER. TWO DAYS LATER, ON (B)(6) 2025, AS THE NURSE WAS INSTILLING TISSUE PLASMINOGEN ACTIVATOR THROUGH THE CHEST TUBE, FLUID LEAKING WAS NOTED. IT WAS ALSO NOTED THAT THE "TUBING BROKE AT THE ENTRY CONNECTION". A CUSTOMER PROVIDED PHOTOGRAPH SHOWS THE HUB DETACHED FROM THE CATHETER SHAFT. A REPEAT CHEST COMPUTED TOMOGRAPHY SCAN WAS PERFORMED, AND THE DEVICE WAS REPLACED ON (B)(6) 2025 WITH AN UNSPECIFIED 12 FR DRAINAGE CATHETER. THE PATIENT ACTIVITY LEVEL AT TIME OF EVENT IS UNKNOWN. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS OCCURRENCE. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL, MANUFACTURING INSTRUCTIONS (MI), SPECIFICATIONS, AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE USED CATHETER WAS RETURNED TO COOK FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS NOTED THE CATHETER, INCLUDING THE FLARE, SEPARATED FROM THE MAC-LOC ADAPTOR. THE FLARE WAS DISTORTED, WITH EVIDENCE OF MATERIAL ELONGATION. NO CATHETER MATERIAL WAS WITHIN THE CAP AND ADAPTOR. THE DISTANCE BETWEEN THE CAP AND THE HUB WAS MEASURED AND WAS DETERMINED TO BE WITHIN SPECIFICATION. COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT ONE DEVICE FROM THE REPORTED COMPLAINT DEVICE LOT AND ITS RELATED SUBASSEMBLY LOTS DID NOT PASS QUALITY CONTROL INSPECTIONS; HOWEVER, THE AFFECTED PRODUCT WAS SCRAPPED PRIOR TO RELEASE FROM COOK. A COMPLAINT HISTORY SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: PRECAUTIONS: PATIENTS WITH INDWELLING DRAINAGE CATHETERS SHOULD BE EVALUATED ROUTINELY TO ENSURE CONTINUOUS FUNCTION OF THE CATHETER. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE AVAILABLE INFORMATION, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE MAIN CAUSE IS COMPONENT FAILURE WITHOUT A MANUFACTURING OR DESIGN DEFICIENCY. IT IS POSSIBLE THAT EXCESSIVE FORCE WAS APPLIED TO THE CATHETER RESULTING IN SEPARATION. HOWEVER, THIS POSSIBILITY CANNOT BE CONFIRMED. 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 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.
IT WAS REPORTED THAT THE MAC-LOC HUB DETACHED FROM AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. THE DEVICE WAS PLACED ON (B)(6) 2025 AS A CHEST TUBE IN A PATIENT OF UNKNOWN AGE AND GENDER. TWO DAYS LATER, ON (B)(6) 2025, AS THE NURSE WAS INSTILLING TISSUE PLASMINOGEN ACTIVATOR THROUGH THE CHEST TUBE, FLUID LEAKING WAS NOTED. IT WAS ALSO NOTED THAT THE "TUBING BROKE AT THE ENTRY CONNECTION". A CUSTOMER PROVIDED PHOTOGRAPH SHOWS THE HUB DETACHED FROM THE CATHETER SHAFT. A REPEAT CHEST COMPUTED TOMOGRAPHY SCAN WAS PERFORMED, AND THE DEVICE WAS REPLACED ON (B)(6) 2025 WITH AN UNSPECIFIED 12 FR DRAINAGE CATHETER. THE PATIENT ACTIVITY LEVEL AT TIME OF EVENT IS UNKNOWN. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS OCCURRENCE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625404 | ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER | FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | COOK INC | G09504 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |