COPE NITINOL MANDRIL WIRE GUIDE
Report
- Report Number
- 1820334-2022-00724
- Event Type
- Injury
- Date Received
- May 16, 2022
- Date of Event
- May 5, 2022
- Report Date
- December 21, 2022
- Manufacturer
- COOK INC
- Product Code
- DQX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED BY A REPRESENTATIVE OF ST. CHARLES HOSPITAL- DENVILLE (UNITED STATES) THAT ON 05MAY2022 A COPE NITINOL MANDRIL WIRE GUIDE (RPN: PMG-18SP-60-COPE-NT; LOT#: UNKNOWN) SEPARATED. THE DEVICE WAS REQUIRED FOR A NEURO DIAGNOSTIC PROCEDURE. THE ACCESS SITE WAS THROUGH THE RIGHT GROIN TO THE COMMON FEMORAL. THERE WAS NO CALCIFICATION AND NO TORTUOSITY OF PATIENT ANATOMY; HOWEVER, THE MUSCLE TISSUE WAS THICK, AND THE FEMORAL ARTERY WAS DEEP IN THE MUSCULAR LAYER. DURING THE PROCEDURE, THE ARTERY WAS ACCESSED WITH THE NEEDLE AND VISUALIZED UNDER ULTRASOUND; HOWEVER, AFTER ADVANCING THE WIRE, THE "NEEDLE LOST ACCESS". THEN UPON REMOVAL OF THE WIRE FROM THE NEEDLE, THERE WAS RESISTANCE AND THE TIP OF THE WIRE FRACTURED; IT WAS NOTED A FRAGMENT OF THE WIRE WAS COILED/KINKED IN SUBCUTANEOUS TISSUE. NO SHARP EDGES WERE NOTED. CONTRALATERAL ACCESS WAS THEN GAINED, AND IT WAS VERIFIED THE WIRE FRAGMENT WAS NOT IN VASCULAR SYSTEM. THE WIRE FRAGMENT WAS LEFT INSIDE PATIENT. IMAGING WAS USED TO VERIFY THE WIRE TIP WAS EXTRAVASCULAR. FURTHER COMMUNICATION WITH THE CUSTOMER INDICATED THERE ARE CURRENTLY NO PLANS TO RETRIEVE THE SEPARATED WIRE GUIDE FRAGMENT "BECAUSE IT WAS A SMALL PORTION AND NOT IN THE VESSEL ¿ ONLY IN THE SUBCUTANEOUS TISSUE". NO OTHER ADVERSE EVENTS WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES OF 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. 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. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER TO AID IN THE INVESTIGATION. A SALES REPORT WAS PERFORMED TO DISCERN A POSSIBLE LOT NUMBER. DUE TO THE AMOUNT OF POSSIBLE LOT NUMBERS, IT WAS NOT POSSIBLE TO ASCERTAIN A LOT NUMBER. BASED ON THE DMR, THE DEVICE HISTORY RECORD, AND WITH NO PRODUCT RETURN, COOK WAS NOT ABLE TO DETERMINE THE PRODUCT OUT OF SPECIFICATION. COOK WAS NOT ABLE TO DETERMINE NON-CONFORMING MATERIAL IN HOUSE OR IN THE FIELD. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MOST RECENT INSTRUCTIONS FOR USE (IFU) T_MWG_REV0 SUPPLIED WITH THE COMPLAINT RPN WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED FAILURE. THE IFU STATES: ¿WARNINGS¿ 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. HOW SUPPLIED.... UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE INFORMATION PROVIDED, INSTRUCTIONS PROVIDED WITH DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE FOR THIS FAILURE IS USER ERROR. THE CUSTOMER STATED THAT WHEN THEY REMOVED THE WIRE THROUGH THE NEEDLE, THE WIRE FRACTURED, AND A PART OF THE DISTAL TIP WAS LEFT IN WITHIN THE PATIENT. 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. 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.
IT WAS REPORTED THAT A COPE NITINOL MANDRIL WIRE GUIDE SEPARATED. THE DEVICE WAS REQUIRED FOR A NEURO DIAGNOSTIC PROCEDURE. THE ACCESS SITE WAS THROUGH THE RIGHT GROIN TO THE COMMON FEMORAL. THERE WAS NO CALCIFICATION AND NO TORTUOSITY OF PATIENT ANATOMY; HOWEVER, THE MUSCLE TISSUE WAS THICK AND THE FEMORAL ARTERY WAS DEEP IN THE MUSCULAR LAYER. DURING THE PROCEDURE, THE ARTERY WAS ACCESSED WITH THE NEEDLE AND VISUALIZED UNDER ULTRASOUND; HOWEVER, AFTER ADVANCING THE WIRE, THE "NEEDLE LOST ACCESS". THEN UPON REMOVAL OF THE WIRE FROM THE NEEDLE, THERE WAS RESISTANCE AND THE TIP OF THE WIRE FRACTURED; IT WAS NOTED A FRAGMENT OF THE WIRE WAS COILED/KINKED IN SUBCUTANEOUS TISSUE. NO SHARP EDGES WERE NOTED. CONTRALATERAL ACCESS WAS THEN GAINED AND IT WAS VERIFIED THE WIRE FRAGMENT WAS NOT IN VASCULAR SYSTEM. THE WIRE FRAGMENT WAS LEFT INSIDE PATIENT. IMAGING WAS USED TO VERIFY THE WIRE TIP WAS EXTRAVASCULAR. ADDITIONAL INFORMATION REGARDING 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.
IN ADDITIONAL INFORMATION, IT WAS REPORTED THERE ARE CURRENTLY NO PLANS TO RETRIEVE THE SEPARATED WIRE GUIDE FRAGMENT "BECAUSE IT WAS A SMALL PORTION AND NOT IN THE VESSEL ¿ ONLY IN THE SUBCUTANEOUS TISSUE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1537123 | COPE NITINOL MANDRIL WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other | MERIT 5.0 FR MICROPUNCTURE. |