ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
Report
- Report Number
- 1820334-2023-00031
- Event Type
- Malfunction
- Date Received
- January 16, 2023
- Date of Event
- January 10, 2023
- Report Date
- April 11, 2023
- Manufacturer
- COOK INC
- Product Code
- GBO
- UDI-DI
- 00827002097056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION ¿ EVALUATION: ON 12JAN2023, (B)(6) RECEIVED A COMPLAINT FROM DR. (B)(6), A REPRESENTATIVE AT THE INSEL GRUPE AG FACILITY, LOCATED IN THE CITY OF BERN, CH. THE ISSUE CONCERNS THE STIFFENING CANNULA (DTN-18-32.5-RLT-DGRM-B) FROM AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER (RPN: ULT8.5-38-25-P-5S-CLDM-HC; LOT: 13965062). DURING INSERTION INTO THE RIGHT PLEURA FOR PLEURAL EFFUSION, THE PHYSICIAN EXPERIENCED DIFFICULTY WHEN ATTEMPTING TO REMOVE THE "TROCAR NEEDLE" FROM THE DRAINAGE CATHETER. HE REPORTED USING THE CORRECT PROCESS DURING THE PERCUTANEOUS PUNCTURE USING THE TROCAR NEEDLE THAT IS PART OF THE DRAINAGE-SET. THE DRAIN AND TROCAR WERE REMOVED TOGETHER AND A NEW SET WAS USED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTIES. THE PATIENT WAS SAID TO HAVE A GOOD OUTCOME. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS OF THE DEVICE, AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST, AND DIMENSIONAL VERIFICATION, WERE CONDUCTED DURING THE INVESTIGATION. THE ULT8.5-38-25-P-5S-CLDM-HC, ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER, WAS RETURNED IN AN OPENED AND USED CONDITION. THE SUPPLIED DTN-18-32.5-RLT-DGRM-B, DISPOSABLE STIFFENING CANNULA WAS RECEIVED INSERTED INTO THE CATHETER. DURING TABLE TOP TESTING THE DISPOSABLE STIFFENING CANNULA WAS ABLE TO BE REMOVED FROM THE CATHETER. THE DISPOSABLE CANNULA WAS REINSERTED AND AGAIN REMOVED FROM THE CATHETER, ENCOUNTERING NO DIFFICULTY. THE DIMENSIONAL VERIFICATION OF THE CATHETER ID AND DISPOSABLE STIFFENER OD CONFIRMED BOTH MEASUREMENTS WERE WITHIN SPECIFICATION WITH NO VISIBLE EVIDENCE OF SURFACE DEFECTS. 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 CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. COOK ALSO REVIEWED THE DEVICE HISTORY RECORD (DHR). THE DHR FOR LOT 13965062 AND ALL POSSIBLE RELATED LOTS CONFIRMED THERE WERE NO RELEVANT RECORDED NONCONFORMANCES. TO DATE, A FURTHER SEARCH OF OUR DATABASE RECORDS REVEALED NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FROM THE REPORTED LOT. SINCE THERE IS OBJECTIVE EVIDENCE THE DHR WAS FULLY EXECUTED, AND THERE ARE NO OTHER LOT-RELATED COMPLAINTS FROM THE FIELD, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD, AND THAT THE DEVICE WAS MANUFACTURED TO CURRENT SPECIFICATIONS. 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: ¿WHEN INSERTING A STIFFENING CANNULA INTO A CATHETER WITH RETENTION SUTURE, HOLD SUTURE DURING CANNULA INSERTION TO AVOID BUNCHING OR TANGLING OF SUTURE.¿ INSTRUCTIONS FOR USE: ¿UNDER FLUOROSCOPIC CONTROL, PERFORM STANDARD TECHNIQUES FOR PLACEMENT OF PERCUTANEOUS DRAINING CATHETERS, EITHER BY SELDINGER ACCESS OR TROCAR ACCESS. -ONCE CATHETER IS IN DESIRED LOCATION, REMOVE ANY WIRE GUIDES, TROCARS, OR STIFFENERS, ALLOWING THE CATHETER TO FOR ITS CONFIGURATION.¿ HOW SUPPLIED: ¿SUPPLIED STERILIZE BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. 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, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK DETERMINED A POTENTIAL CAUSE OF THIS EVENT IS RELATED TO A COMPONENT FAILURE WITHOUT ANY MANUFACTURING OR DESIGN DEFICIENCY. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CUSTOMER (PERSON): (B)(6) . PMA/510(K) #: EXEMPT. 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.
E1: CUSTOMER (PERSON): POSTAL CODE: (B)(6). PHONE: (B)(6). FAX: (B)(6). 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IT WAS REPORTED THAT "THE NEEDLE WAS BLOCKED AND COULDN'T BE RETRIEVED" FROM AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. IT IS ASSUMED, PENDING FURTHER INFORMATION, THAT THE METAL STIFFENING CANNULA WAS DIFFICULT TO REMOVE FROM THE DRAINAGE CATHETER. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
ADDITIONAL INFORMATION WAS RECEIVED 17JAN2023. THE PATIENT WAS REPORTED TO BE A FEMALE BORN IN 1940 WITH "REDUCED GENERAL CONDITION" AND WITHOUT CALCIFIED OR TORTUOUS ANATOMY. DURING AN ULTRASONICALLY CONTROLLED DRAINAGE INSERT IN THE RIGHT PLEURA FOR PLEURAL EFFUSION, THE PHYSICIAN HAD DIFFICULTY REMOVING THE "TROCAR NEEDLE" FROM THE DRAINAGE CATHETER. HE REPORTED USING CORRECT PROCESS DURING THE PERCUTANEOUS PUNCTURE USING THE TROCAR NEEDLE THAT IS PART OF THE DRAINAGE-SET. THE DRAIN AND TROCAR WERE REMOVED TOGETHER AND A NEW SET WAS USED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTIES. THE PATIENT WAS SAID TO HAVE A GOOD OUTCOME. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1656275 | ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER | GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY | GBO | COOK INC | N/A | 13965062 | 00827002097056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female |