FLEXOR RAABE GUIDING SHEATH
Report
- Report Number
- 1820334-2019-02977
- Event Type
- Malfunction
- Date Received
- November 27, 2019
- Report Date
- March 10, 2020
- Manufacturer
- COOK INC
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
G5: PMA/510(K) NUMBER = PRE-AMENDMENT. 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.
PMA/510K= K142829. THIS MDR IS BEING SUBMITTED AS HAVING INFORMATION NOT PREVIOUSLY REPORTED. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. EVENT SUMMARY: AS REPORTED, DURING A LOWER EXTREMITY INTERVENTION, A FLEXOR RAABE GUIDING SHEATH SEPARATED. THE UNRAVELED SHEATH WAS REMOVED FROM THE BODY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION ¿ EVALUATION: REVIEWS OF THE DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS WERE CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS NOT RETURNED AND THUS A DEVICE FAILURE ANALYSIS ON THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AS THE LOT NUMBER WAS UNKNOWN A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. A PREVIOUSLY CLOSED CAPA DETERMINED THAT THE SEPARATION FAILURES OF THE FLEXOR INTRODUCER SHEATH DEVICES ARE BASED UPON THE USE OF THE DEVICE RATHER THAN ANY MANUFACTURING OR DESIGN NON-CONFORMANCES. INSPECTION ACTIVITIES ARE IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. BASED ON THE LIMITED INFORMATION PROVIDED AND NO PRODUCT RETURNED, THE INVESTIGATION HAS CONCLUDED THAT A CAUSE FOR THIS COMPLAINT COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE INSTRUCTIONS FOR USE (IFU) INCLUDED WITH THIS DEVICE WARNS TO REINSERT THE DILATOR PRIOR TO REMOVAL. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, THE INVESTIGATION HAS CONCLUDED THAT A CAUSE FOR THIS COMPLAINT COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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.
ADDITIONAL INFORMATION RECEIVED 27NOV2019. THE PROCEDURE WAS A LOWER EXTREMITY INTERVENTION. THE UNRAVELED SHEATH WAS REMOVED FROM THE BODY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
COMMON NAME & PRODUCT CODE = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. OCCUPATION - UNKNOWN. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE FLEXOR RAABE GUIDING SHEATH SEPARATED WHILE BEING USED ON A PATIENT WITH UNKNOWN DEMOGRAPHICS. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY, PRODUCT DETAILS, AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1182529 | FLEXOR RAABE GUIDING SHEATH | DYB INTRODUCER, CATHETER | DYB | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |