UNKNOWN
Report
- Report Number
- 1820334-2020-02078
- Event Type
- Malfunction
- Date Received
- November 12, 2020
- Date of Event
- October 26, 2020
- Report Date
- January 5, 2021
- Manufacturer
- COOK INC
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. 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.
ADDITIONAL INFORMATION: D4: UNSPECIFIED 6FR KSAW ANSEL SHEATH. DESCRIPTION OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE AN UNSPECIFIED 6FR ANSEL SHEATH SEPARATED FROM THE TUOHY BORST FITTING. THE HUB, WHICH WAS USED TO PULL THE DEVICE FROM THE PATIENT, SEPARATED FROM THE SHEATH UPON REMOVAL OF THE DEVICE. NO OTHER DEVICE, INCLUDING THE DILATOR, WAS IN THE LUMEN OF THE SHEATH AT THE TIME OF SEPARATION; HOWEVER, THE SHEATH AND DILATOR WERE REPORTEDLY WITHDRAWN AS A UNIT. THE PATIENT DID NOT EXPERIENCE BLOOD LOSS. NOTHING REMAINED IN THE PATIENT, AND NO ADDITIONAL INTERVENTIONS WERE REQUIRED. INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. THE COMPLAINANT RETURNED THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED: ONE USED 6FR KSAW SHEATH WAS RECEIVED. BIOMATTER WAS PRESENT, AND THE SHEATH MATERIAL WAS SEPARATED FROM THE FITTING. THE SHEATH LENGTH FROM THE DISTAL END OF THE FLARE WAS 62.2 CM WITH ELONGATION STARTING AT 9 CM FROM THE FAILURE AND HAVING A LENGTH OF 15 CM. RADIOPAQUE BAND WAS PRESENT. NO ADDITIONAL DAMAGE WAS NOTED. DIMENSIONS RELATED TO THE FAILURE WERE ANALYZED AND COOK CONCLUDED THAT THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATION. 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), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: ¿REINSERTION OF DILATOR PRIOR TO REMOVAL OF FLEXOR SHEATH INCREASES THE STRENGTH OF THE SHEATH AND LESSENS THE RISK OF DEVICE SEPARATION. IF RESISTANCE IS ANTICIPATED OR ENCOUNTERED DURING WITHDRAWAL OF FLEXOR SHEATH, CONSIDER CAREFULLY REINSERTING THE DILATOR PRIOR TO CONTINUING REMOVAL.¿ INSTRUCTIONS FOR USE: SHEATH REMOVAL: ¿2. REMOVE THE SHEATH. AVOID APPLYING TRACTION TO HUB DURING REMOVAL. IF RESISTANCE IS ANTICIPATED OR ENCOUNTERED DURING WITHDRAWAL OF THE FLEXOR SHEATH, CONSIDER REINSERTING THE DILATOR AND REMOVING THE SHEATH AND DILATOR AS A UNIT.¿ A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. FINDINGS OF THIS INVESTIGATION REVEALED NO EVIDENCE TO SUGGEST THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. IT IS UNKNOWN WHETHER THE PATIENT HAD TORTUOUS ANATOMY IN THE LOCATION WHERE THE HUB SEPARATED. A PREVIOUSLY OPENED CAPA SHOWED CLINICAL USERS MAY BE USING THESE DEVICES TO FORCE THROUGH RESTRICTIVE ANATOMY CAUSING SEPARATION UPON REMOVAL. IT IS POSSIBLE FORCE WAS USED DURING ADVANCEMENT WHICH COULD HAVE CAUSED THE HUB TO SEPARATE ON REMOVAL. THE INVESTIGATION CONCLUSION FOR THIS COMPLAINT IS CAUSE TRACED TO PATIENT ANATOMY AND PROCEDURE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK 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 WAS RECEIVED 16NOV2020. THE HUB, WHICH WAS USED TO PULL THE DEVICE FROM THE PATIENT, SEPARATED FROM THE SHEATH UPON REMOVAL OF THE DEVICE. NO OTHER DEVICE, INCLUDING THE DILATOR, WAS IN THE LUMEN OF THE SHEATH AT THE TIME OF SEPARATION; HOWEVER, THE SHEATH AND DILATOR WERE REPORTEDLY WITHDRAWN AS A UNIT. THE PATIENT DID NOT EXPERIENCE BLOOD LOSS. NOTHING REMAINED IN THE PATIENT, AND NO ADDITIONAL INTERVENTIONS WERE REQUIRED.
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
PRODUCT IDENTIFIER: UNSPECIFIED 6FR ANSEL SHEATH. OCCUPATION: (B)(6). 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 UNKNOWN PROCEDURE AN UNSPECIFIED 6FR ANSEL SHEATH SEPARATED FROM THE TUOHY BORST FITTING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1294307 | UNKNOWN | DYB INTRODUCER, CATHETER | DYB | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |