FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
Report
- Report Number
- 1820334-2020-00522
- Event Type
- Injury
- Date Received
- March 2, 2020
- Date of Event
- February 24, 2020
- Report Date
- April 30, 2020
- Manufacturer
- COOK INC
- Product Code
- DYB
- PMA / PMN Number
- K142829
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS INITIALLY REPORTED, DURING AN ANGIOGRAM OF THE DISTAL SUPERFICIAL FEMORAL OR POPLITEAL ARTERY VIA COMMON FEMORAL ARTERY ACCESS, A FLEXOR RAABE GUIDING SHEATH SEPARATED AT THE SHAFT UPON REMOVAL OF THE DEVICE. THE ANATOMY WAS REPORTEDLY CALCIFIED. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE. THE DILATOR WAS NOT IN PLACE AT THE TIME OF SEPARATION; HOWEVER, AN UNKNOWN WIRE GUIDE WAS IN THE LUMEN OF THE SHEATH WHEN THE DEVICE SEPARATED. AN UNKNOWN SNARE WAS USED TO RETRIEVE THE SEPARATED PORTION OF THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT IS REPORTEDLY "FINE". 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. ADDITIONAL INFORMATION RECEIVED 11MAR2020. THE COMPLAINT DEVICE WAS NOT A FLEXOR RAABE GUIDING SHEATH AS ORIGINALLY REPORTED, BUT RATHER A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH. MODERATE ATHEROSCLEROSIS WAS REPORTED NEAR THE ACCESS SITE AND AT THE LEFT COMMON ILIAC ARTERY. MODERATE CALCIFICATION THE LEFT COMMON ILIAC ARTERY WAS REPORTED. A COOK 4MM BALLOON AND ANOTHER MANUFACTURER'S BALLOON WERE UTILIZED THROUGH THE DEVICE TO PERFORM ANGIOPLASTY. NO KINKS WERE NOTED PRIOR TO USE OF THE DEVICE. NO RESISTANCE WAS FELT DURING INSERTION OR REMOVAL OF THE DEVICE. THE SHEATH WAS IN PLACE APPROXIMATELY ONE HOUR. THE DILATOR WAS NOT IN PLACE DURING SEPARATION OF THE DEVICE. THE SEPARATION OCCURRED APPROXIMATELY TEN CENTIMETERS FROM THE SHEATH TIP. AN UNKNOWN 7 FRENCH SHEATH WAS USED WITH A SNARE TO REMOVE THE SEPARATED PORTION OF THE DEVICE, VIA ACCESS IN THE LEFT LEG. PRESSURE WAS HELD AFTER REMOVAL. THE PROCEDURE WAS ABORTED PRIOR TO A SECONDARY ANGIOPLASTY. THE PATIENT WAS DISCHARGED ONE DAY AFTER THE PROCEDURE, AS WAS PREVIOUSLY PLANNED, WITH IMPROVEMENT IN SYMPTOMS. INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION, AS WELL AS A VISUAL INSPECTION OF THE COMPLAINT DEVICE. THE COMPLAINT DEVICE WAS RETURNED FOR INVESTIGATION WITH BIOMATTER PRESENT AND SEPARATED INTO TWO PIECES. THE PROXIMAL SECTION MEASURED 61.3 CENTIMETERS AND THE DISTAL SEGMENT MEASURED 8CM. A KINK WAS NOTED IN THE PROXIMAL SECTION. THE INNER COIL EXITED BOTH SEPARATION POINTS. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO LOT RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. GIVEN THIS INFORMATION, THERE IS OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO COOK¿S SPECIFICATIONS. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE PRODUCT IFU WARNS: "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." THE IFU ALSO STATES: "REINSERTION OF THE 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." COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE FAILURE OF THE PHYSICIAN TO REINSERT THE DILATOR PRIOR TO THE REMOVAL OF THE DEVICE AND THE PRESENCE OF CALCIFICATION IN THE PATIENT¿S VESSELS LIKELY CONTRIBUTED TO THIS INCIDENT. RISK WAS ASSESSED FOR THIS COMPLAINT EVENT. NO RISK ESCALATION ACTIVITIES ARE REQUIRED; HOWEVER, A CAPA REMAINS OPEN TO INVESTIGATE THE FAILURE OF FLEXOR SHEATH SHAFT SEPARATION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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 OR UNAVAILABLE. CORRECTION: D1 ADDITIONAL INFORMATION: B5 (RECEIVED 11MAR2020), B7, D4 (RECEIVED 06MAR2020), D11 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.
ADDITIONAL INFORMATION WAS RECEIVED 11MAR2020 AND WAS INADVERTENTLY OMITTED FROM THE LAST MDR SUBMITTED. MODERATE CALCIFICATION THE LEFT COMMON ILIAC ARTERY WAS REPORTED. THE SEPARATION OCCURRED APPROXIMATELY TEN CENTIMETERS FROM THE SHEATH TIP. AN UNKNOWN 7 FRENCH SHEATH WAS USED WITH A SNARE TO REMOVE THE SEPARATED PORTION OF THE DEVICE, VIA ACCESS IN THE LEFT LEG. PRESSURE WAS HELD AFTER REMOVAL. THE PROCEDURE WAS ABORTED PRIOR TO A SECONDARY ANGIOPLASTY.
ADDITIONAL INFORMATION RECEIVED 11MAR2020. MODERATE ATHEROSCLEROSIS WAS REPORTED NEAR THE ACCESS SITE AND AT THE LEFT COMMON ILIAC ARTERY. A COOK 4MM BALLOON AND ANOTHER MANUFACTURER'S BALLOON WERE UTILIZED THROUGH THE DEVICE TO PERFORM ANGIOPLASTY. NO KINKS WERE NOTED PRIOR TO USE OF THE DEVICE. NO RESISTANCE WAS FELT DURING INSERTION OR REMOVAL OF THE DEVICE. THE SHEATH WAS IN PLACE APPROXIMATELY ONE HOUR. THE DILATOR WAS NOT IN PLACE DURING SEPARATION OF THE DEVICE. THE PATIENT WAS DISCHARGED ONE DAY AFTER THE PROCEDURE, AS WAS PREVIOUSLY PLANNED, WITH IMPROVEMENT IN SYMPTOMS.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. PMA/510(K) NUMBER = 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 ANGIOGRAM OF THE DISTAL SUPERFICIAL FEMORAL OR POPLITEAL ARTERY VIA COMMON FEMORAL ARTERY ACCESS, A FLEXOR RAABE GUIDING SHEATH SEPARATED AT THE SHAFT UPON REMOVAL OF THE DEVICE. THE ANATOMY WAS REPORTEDLY CALCIFIED. IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE. THE DILATOR WAS NOT IN PLACE AT THE TIME OF SEPARATION; HOWEVER, AN UNKNOWN WIRE GUIDE WAS IN THE LUMEN OF THE SHEATH WHEN THE DEVICE SEPARATED. AN UNKNOWN SNARE WAS USED TO RETRIEVE THE SEPARATED PORTION OF THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT IS REPORTEDLY "FINE". 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236476 | FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH | DYB INTRODUCER, CATHETER | DYB | COOK INC | 10264772 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 4MM BALLOON, 3MM MEDTRONIC CHOCOLATE PTA BALLOON. |