DYB INTRODUCER, CATHETER
Report
- Report Number
- 1820334-2020-02361
- Event Type
- Injury
- Date Received
- December 28, 2020
- Report Date
- April 20, 2021
- Manufacturer
- COOK INC
- Product Code
- DYB
- PMA / PMN Number
- K142829
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. DESCRIPTION OF EVENT: AS REPORTED, DURING AN ANGIOGRAM VIA DOWNHILL PUNCTURE AN UNSPECIFIED COOK FLEXOR 6X45 SHEATH SEPARATED AT THE HUB. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY AND THE SHEATH WAS IN PLACE FOR ONE HOUR. THE ACCESS SITE WAS SCARRED AND RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE SHEATH. THE HUB OF THE SHEATH WAS USED TO PULL THE DEVICE FROM THE PATIENT AND FORCE WAS USED DURING REMOVAL. THE DILATOR WAS NOT IN PLACE AT THE TIME OF REMOVAL OR HUB SEPARATION; HOWEVER A WIRE GUIDE WAS IN PLACE FOR INSERTION OF A CLOSURE DEVICE. HEPARIN AND CONTRAST WERE GIVEN DURING THE PROCEDURE. AFTER THE HUB SEPARATED, THE SHEATH WAS REMOVED WITH A HEMOSTAT AND PRESSURE WAS APPLIED TO THE ACCESS SITE. THE SHEATH WAS RETRIEVED USING FORCEPS. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. 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. ONE SEPARATED 6.0FR FLEXOR SHEATH WAS RETURNED. THE CHECK-FLO BODY WAS SEPARATED FROM THE SHEATH. THE PROXIMAL FLARE WAS INTACT. THE SHEATH WAS WRINKLED 19.1CM FROM THE FLARE. THE SHEATH IS ONE SECTION OF DARK BLUE TUBING AND MEASURES 45.3CM IN LENGTH. THE CONNECTOR CAP INNER DIAMETER MEASURED WITHIN SPECIFICATION. AS NO PRODUCT LOT WAS PROVIDED, REVIEWS OF THE DEVICE HISTORY RECORD OR COMPLAINT HISTORY COULD NOT BE CONDUCTED. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: "WARNINGS -IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OF FLEXOR SHEATH, ASSESS CAUSE OF RESISTANCE AND CONSIDER DILATION OF ANY RESTRICTION IDENTIFIED OR CONSIDER ALTERNATE TREATMENT STRATEGY. IF FLEXOR SHEATH IS ADVANCED THROUGH RESISTANCE, FORCE TO REMOVE THE SHEATH WILL BE HIGHER, INCREASING THE RISK OF SHEATH MATERIAL OR HUB SEPARATION UPON WITHDRAWAL. -REINSERTION OF DILATOR PRIOR TO REMOVAL OF FLEXOR SHEATH INCREASES THE STRENGTH OF THE SHEATH ND 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. SHEATH REMOVAL 1. INSERT WIRE GUIDE UNTIL ITS TIP EXTENDS AT LEAST 10CM PAST THE TIP OF THE SHEATH. 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. 3. REMOVE THE WIRE GUIDE." 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. THE USER INFORMED COOK THAT THE DILATOR WAS NOT USED AND RESISTANCE WAS NOTED UPON REMOVAL. THE IFU INSTRUCTS TO REINSERT THE DILATOR TO AVOID DEVICE SEPARATION IF RESISTANCE IS NOTED DURING REMOVAL. IT WAS ALSO REPORTED THAT THE PATIENT'S ANATOMY WAS SCARRED AT THE ACCESS SITE. BASED ON THIS INFORMATION, THE MOST LIKELY CAUSES OF THIS EVENT ARE UNINTENDED USE ERROR AND PATIENT ANATOMY. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. H3: DEVICE EVALUATED BY MFG = OTHER (81) - DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. D10, H3: IT IS POSSIBLE THAT THE DEVICE WILL BE RETURNED. 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.
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.
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
ADDITIONAL INFORMATION WAS RECEIVED 03MAR2021. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY AND THE SHEATH WAS IN PLACE FOR ONE HOUR. THE ACCESS SITE WAS SCARRED AND RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE SHEATH. THE HUB OF THE SHEATH WAS USED TO PULL THE DEVICE FROM THE PATIENT AND FORCE WAS USED DURING REMOVAL. THE DILATOR WAS NOT IN PLACE AT THE TIME OF REMOVAL OR HUB SEPARATION; HOWEVER A WIRE GUIDE WAS IN PLACE FOR INSERTION OF A CLOSURE DEVICE. HEPARIN AND CONTRAST WERE GIVEN DURING THE PROCEDURE. AFTER THE HUB SEPARATED, THE SHEATH WAS REMOVED WITH A HEMOSTAT AND PRESSURE WAS APPLIED TO THE ACCESS SITE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM THE LAST MDR. THE PROCEDURE WAS AN ANGIOGRAM OF THE LEFT LEG VIA "DOWNHILL" PUNCTURE. THE GROIN WAS SCARRED FROM PREVIOUS ANGIOGRAMS. THE DEVICE WAS DIFFICULT TO ADVANCE OVER AN UNSPECIFIED STIFF AMPLATZ WIRE. THE PATIENT EXPERIENCED PAIN ON REMOVAL.
ADDITIONAL INFORMATION RECEIVED ON 18JAN2021: IT WAS FOUND THAT THE USER FELT RESISTANCE WHILE ATTEMPTING TO ADVANCE THE SHEATH OVER AND AMPLATE WIRE. THEN WHILE TRYING TO REMOVE THE DEVICE THE HUB SEPARATED FROM THE SHAFT.
DATE OF EVENT: A FEW DAYS PRIOR TO DATE AWARE (08DEC2020). SUSPECT MEDICAL DEVICE: 6 FR 45 FLEXOR ANSEL GUIDING SHEATH. PMA/510(K) NUMBER = PER THE DEVICE DESCRIPTION, THE 510(K) IS LIKELY K142829. (B)(4). 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 COOK FLEXOR 6X45 SHEATH SEPARATED AT THE HUB. THE SHEATH WAS RETRIEVED USING FORCEPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1545216 | DYB INTRODUCER, CATHETER | DYB | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | AMPLATZ EXTRA STIFF.| GLIDEWIRE.| RIM CATHETER. |