COPE NITINOL MANDRIL WIRE GUIDE
Report
- Report Number
- 1820334-2022-01666
- Event Type
- Injury
- Date Received
- October 29, 2022
- Date of Event
- May 4, 2022
- Report Date
- April 10, 2023
- Manufacturer
- COOK INC
- Product Code
- DQX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
OCCUPATION: RISK MANAGER. PMA/510(K) #: K171997. 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.
INVESTIGATION ¿ EVALUATION IT WAS REPORTED BY A REPRESENTATIVE OF (B)(6) HOSPITAL- DENVILLE (UNITED STATES) ON 24OCT2022 THAT A COPE NITINOL MANDRIL WIRE GUIDE (RPN: PMG-18SP-60-COPE-NT; LOT#: 14435750) SEPARATED. THE DEVICE WAS REQUIRED ON (B)(6) 2022 BY AN UNKNOWN PATIENT FOR USE DURING TREATMENT OF A LEFT BASAL GANGLIA HEMORRHAGE. A 5 FRENCH MICROPUNCTURE KIT (MANUFACTURER, RPN, AND LOT# UNKNOWN) WAS USED TO ACCESS THE RIGHT FEMORAL ARTERY WITH ULTRASOUND AND FLUOROSCOPIC GUIDANCE. THE COPE WIRE WAS DIFFICULT TO ADVANCE. AFTER THREE UNSUCCESSFUL ATTEMPTS TO ADVANCE THE COPE WIRE INTO THE FEMORAL ARTERY, THE WIRE WAS REMOVED, FOLLOWED BY THE NEEDLE. AFTER THE WIRE WAS REMOVED, FLUOROSCOPIC IMAGING REVEALED A PORTION OF THE WIRE WAS RETAINED IN THE PATIENT NEAR THE ACCESS SITE. ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WAS REQUESTED BUT NOT RECEIVED. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES FOR THE 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. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT 14435750 REVEALED THREE RELEVANT NON-CONFORMANCES: STRETCHED COILS, OFF-SET COILS, AND INSUFFICIENT SOLDER. ALL DEFECTIVE DEVICES WERE SCRAPPED. THESE DEVICES ARE 100% INSPECTED FOR DAMAGE. THERE ARE NO OTHER COMPLAINTS ON THIS LOT. BASED ON THE DEVICE MASTER RECORD, THE DEVICE HISTORY RECORD, AND WITH NO PRODUCT RETURN, COOK WAS NOT ABLE TO DETERMINE THE PRODUCT MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE INSTRUCTIONS FOR USE (IFU) [T_MWG_REV0] SUPPLIED WITH THE COMPLAINT RPN WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED FAILURE MODE AND ARE FURTHER DETAILED IN THE INVESTIGATION BELOW. THE IFU STATES: ¿WARNINGS: THIS PRODUCT IS A DELICATE INSTRUMENT. AVOID FORCEFUL ANGULATION. AVOID MANIPULATING OR WITHDRAWING THE WIRE GUIDE BACK THROUGH A METAL NEEDLE OR CANNULA. A SHARP EDGE MAY SCRAPE OR SHEAR MATERIAL FROM THE WIRE GUIDE. ALTERING THE TIP¿S CONFIGURATION OR CURVE MANUALLY MAY DAMAGE THE WIRE GUIDE¿" BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THE CAUSE OF THIS EVENT WAS UNINTENDED USER ERROR. PROVIDED LABELING INDICATES NOT TO REMOVE THE WIRE GUIDE BACK OUT OF A NEEDLE. 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.
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, 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.
IT WAS REPORTED A COPE NITINOL MANDRIL WIRE GUIDE WAS USED FOR FEMORAL ARTERY ACCESS. A 5F MICROPUNCTURE KIT WAS USED TO ACCESS THE RIGHT FEMORAL ARTERY UNDER ULTRASOUND AND FLUOROSCOPIC GUIDANCE ON A PATIENT WITH THE PRE-EXISTING CONDITION ACUTE LEFT BASAL GANGLIA HEMORRHAGE. THE MICROWIRE WAS DIFFICULT TO ADVANCE. THE MICROWIRE, FOLLOWED BY THE NEEDLE, WAS REMOVED AFTER THREE ATTEMPTS WERE MADE TO ACCESS THE RIGHT FEMORAL ARTERY. A RETAINED PORTION OF THE MICROWIRE WAS NOTED ON THE FLUOROSCOPE AROUND THE RIGHT FEMORAL ACCESS SITE IN THE PATIENT'S BODY AFTER REMOVAL OF THE MICROWIRE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
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 |
|---|---|---|---|---|---|---|---|
| 2911200 | COPE NITINOL MANDRIL WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | N/A | 14435750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Disability| O |