ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
Report
- Report Number
- 1820334-2021-02655
- Event Type
- Injury
- Date Received
- December 9, 2021
- Date of Event
- November 3, 2021
- Report Date
- October 7, 2022
- Manufacturer
- COOK INC
- Product Code
- FGE
- UDI-DI
- 00827002094970
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL COMMON NAME: LJE CATHETER, NEPHROSTOMY; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY. ADDITIONAL PRO CODE: LJE, GBO. CUSTOMER (PERSON): PHONE: (B)(6). OCCUPATION: UNKNOWN. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION IT WAS REPORTED BY (B)(6) OF (B)(6) HOSPITAL OF (B)(6) THAT THE SUTURE OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER (RPN: ULT8.5-38-40-P-32S-CLB-RH, LOT#: 14084628) BROKE AFTER DEVICE PLACEMENT. THE DEVICE WAS REQUIRED BY A 55-YEAR-OLD-MALE FOR DRAINAGE OF A LIVER ABSCESS. ON (B)(6) 2021 AT 09:35HRS THE DEVICE WAS PLACED VIA A COMPUTED TOMOGRAPHY (CT) GUIDED PUNCTURE AND THE PROCEDURE WAS COMPLETED AT 10:00HRS. WHILE IN THE RECOVERY AREA, THE SUTURE ON THE DRAINAGE CATHETER SEPARATED RESULTING IN FAILURE OF THE DRAIN. THE PATIENT REPORTED NO DISCOMFORT, SO AN ADDITIONAL PROCEDURE TO REPLACE THE DEVICE WAS PERFORMED. AFTER THE SECOND PROCEDURE WAS COMPLETE, IMAGING WAS PERFORMED, AND A SMALL PNEUMOTHORAX WAS DISCOVERED. HOWEVER, IT WAS NOTED THAT ¿THIS WAS NOT RELATED TO THE PLACEMENT OF THE BILIARY DRAIN¿. AGAIN, THE PATIENT DID NOT EXPRESS DISCOMFORT, SO HE THEN RETURNED TO THE WARD FOR FURTHER OBSERVATION. NO OTHER ADVERSE EVENTS RELATED TO THIS OCCURRENCE HAVE BEEN REPORTED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR (B)(4) DISCOVERED ONE RELEVANT RECORDED NONCONFORMANCE FOR "STRING HOLE INCORRECT PLACEMENT". THIS NONCONFORMING DEVICE WAS SCRAPPED PRIOR TO FURTHER PROCESSING. THE SUTURE LOT 2142951.1 IS SUPPLIED BY ANOTHER MANUFACTURER. THERE WERE NO ABNORMALITIES RECORDED DURING THE INCOMING INSPECTION PROCESS. IN ADDITION, THE SUPPLIER PROVIDED A CERTIFICATION OF COMPLIANCE, INDICATING THE SUTURE STRING MET THE REQUIRED TENSILE STRENGTH REQUIREMENT. THERE IS OBJECTIVE EVIDENCE THE DHR WAS EXECUTED, AND THERE ARE NO ADDITIONAL FIELD COMPLAINTS ON THIS LOT. COOK DID NOT FIND EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_MULTI_REV5] ¿MULTIPURPOSE DRAINAGE CATHETER,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: ¿TRACTION ON THE LOCKING SUTURE, IF PRESENT, SHOULD BE SUFFICIENT TO ENSURE ADEQUATE RETENTION OF THE TIP, BUT SHOULD NOT BE OVERLY TIGHT.¿ INSTRUCTIONS FOR USE: MAC-LOC LOCKING LOOP MECHANISM: A. ¿STABILIZE THE MAC-LOC CATHETER HUB ASSEMBLY WITH ONE HAND AND PULL BACK ON THE DRAWSTRING TO FORM THE DISTAL CATHETER LOOP CONFIGURATION. (FIG. 1) B. WHILE MAINTAINING TRACTION ON THE DRAWSTRING, PUSH THE LOCKING CAM LEVER DOWN UNTIL A DISTINCT ¿SNAP¿ IS FELT. THE DISTAL LOOP OF THE CATHETER IS NOW LOCKED IN POSITION. (FIG. 2)¿ HOW SUPPLIED: ¿SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGE. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED, NO RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT IS RELATED TO A COMPONENT FAILURE WITHOUT A MANUFACTURING OR DESIGN DEFICIENCY. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. 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.
ADDITIONAL COMMON NAME: LJE CATHETER, NEPHROSTOMY; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY. ADDITIONAL PRO CODE: LJE, GBO. CUSTOMER (PERSON): PHONE: (B)(6). OCCUPATION: UNKNOWN. 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.
IT WAS REPORTED THAT THE SUTURE STRING OF A ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER BROKE FOLLOWING A LIVER ABSCESS DRAINAGE PROCEDURE. ON (B)(6) 2021 AT 09:35, THE PATIENT UNDERWENT A CT GUIDED PUNCTURE AND LIVER ABSCESS DRAINAGE WITH A BILIARY DRAINAGE CATHETER, THE PUNCTURE AND CATHETER PLACEMENT WAS COMPLETED AT 10:00, HOWEVER THE SUTURE STRING SUDDENLY BROKE DURING THE RECOVERY PROCESS FOLLOWING THE PROCEDURE AND RESULTED IN CATHETER PLACEMENT FAILURE. THE PATIENT WAS FOUND TO HAVE NO DISCOMFORT. THE CATHETER WAS THEN REMOVED AND A NEW DEVICE WAS PLACED SUCCESSFULLY. FOLLOWING CATHETERIZATION, A SMALL AMOUNT OF PNEUMOTHORAX WAS FOUND ON A SCAN, HOWEVER THE PATIENT DID NOT COMPLAIN OF ANY DISCOMFORT AND WAS RETURNED TO THE WARD FOR FURTHER OBSERVATION. IT WAS LATER CLARIFIED THAT THE PATIENT HAD NO UNCOMFORTABLE SYMPTOMS AFTER THE FIRST PUNCTURE, HOWEVER THE PATIENT DEVELOPED PNEUMOTHORAX SYMPTOMS FOLLOWING THE SECOND PUNCTURE. THIS WAS BELIEVED TO BE DUE TO THE PATIENT'S "TIGHTNESS AND SHORTNESS OF BREATH" AND NOT DUE TO THE PLACEMENT OF THE BILIARY DRAIN.
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 STRING OF A ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER BROKE FOLLOWING A LIVER ABSCESS DRAINAGE PROCEDURE. ON (B)(6) 2021 AT 09:35, THE PATIENT UNDERWENT A CT GUIDED PUNCTURE AND LIVER ABSCESS DRAINAGE WITH A BILIARY DRAINAGE CATHETER, THE PUNCTURE AND CATHETER PLACEMENT WAS COMPLETED AT 10:00, HOWEVER THE SUTURE STRING SUDDENLY BROKE DURING THE RECOVERY PROCESS FOLLOWING THE PROCEDURE AND RESULTED IN CATHETER PLACEMENT FAILURE. THE PATIENT WAS FOUND TO HAVE NO DISCOMFORT. THE CATHETER WAS THEN REMOVED AND A NEW DEVICE WAS PLACED SUCCESSFULLY. FOLLOWING CATHETERIZATION, A SMALL AMOUNT OF PNEUMOTHORAX WAS FOUND ON A SCAN, HOWEVER THE PATIENT DID NOT COMPLAIN OF ANY DISCOMFORT AND WAS RETURNED TO THE WARD FOR FURTHER OBSERVATION. IT WAS LATER CLARIFIED THAT THE PATIENT HAD NO UNCOMFORTABLE SYMPTOMS AFTER THE FIRST PUNCTURE, HOWEVER THE PATIENT DEVELOPED PNEUMOTHORAX SYMPTOMS FOLLOWING THE SECOND PUNCTURE. THIS WAS BELIEVED TO BE DUE TO THE PATIENT'S "TIGHTNESS AND SHORTNESS OF BREATH" AND NOT DUE TO THE PLACEMENT OF THE BILIARY DRAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1868499 | ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK INC | N/A | 14084628 | 00827002094970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Required Intervention |