UNKNOWN
Report
- Report Number
- 1820334-2024-00877
- Event Type
- Injury
- Date Received
- June 27, 2024
- Date of Event
- May 29, 2024
- Report Date
- December 12, 2024
- Manufacturer
- COOK INC
- Product Code
- DYB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
G4: PMA/510(K) # - K171275, K172980, OR K171999. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, A PIECE BROKE OFF AN UNSPECIFIED "STIFF MICROPUNCTURE". A CUT DOWN WAS PERFORMED TO REMOVE THE SEPARATED PORTION OF THE UNSPECIFIED COMPONENT. PER THE REPORTER, THE PATIENT IS DOING "FINE". THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE. ADDITIONAL INFORMATION WAS RECEIVED 08JUL2024. UPON GAINING ULTRASOUND-GUIDED ACCESS WITH THE 21-GAUGE NEEDLE, THE NEEDLE BROKE OFF DURING INSERTION INTO THE FEMORAL ARTERY. BLOOD RETURN WAS NOTED UPON INSERTION OF THE NEEDLE. THE ACCESS SITE WAS SCARRED, AND RESISTANCE WAS ENCOUNTERED DURING INSERTION AND REMOVAL OF THE NEEDLE. REPORTEDLY, THE NEEDLE DID NOT MIGRATE PAST THE ACCESS SITE, AND ADDITIONAL SURGICAL TOOLS WERE USED TO REMOVE THE NEEDLE FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED TO COOK, AND A SEARCH OF SALES HISTORY COULD NOT DETERMINE THE LOT; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE PATIENT¿S SCARRED ANATOMY CONTRIBUTED TO THIS EVENT, AS RESISTANCE WAS ENCOUNTERED UPON BOTH INSERTION AND REMOVAL OF THE NEEDLE. IF ENOUGH FORCE WAS USED, IT COULD HAVE CAUSED THE NEEDLE TO BREAK. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. 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, UNAVAILABLE OR UNCHANGED. ADDITIONAL INFORMATION: B5, E4. CORRECTION: H6 ANNEX G, H8. 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.
AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, A PIECE BROKE OFF AN UNSPECIFIED "STIFF MICROPUNCTURE". A CUT DOWN WAS PERFORMED TO REMOVE THE SEPARATED PORTION OF THE UNSPECIFIED COMPONENT. PER THE REPORTER, THE PATIENT IS DOING "FINE". THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION WAS RECEIVED 08JUL2024. UPON GAINING ULTRASOUND-GUIDED ACCESS WITH THE 21-GAUGE NEEDLE, THE NEEDLE BROKE OFF DURING INSERTION INTO THE FEMORAL ARTERY. BLOOD RETURN WAS NOTED UPON INSERTION OF THE NEEDLE. THE ACCESS SITE WAS SCARRED, AND RESISTANCE WAS ENCOUNTERED DURING INSERTION AND REMOVAL OF THE NEEDLE. REPORTEDLY, THE NEEDLE DID NOT MIGRATE PAST THE ACCESS SITE, AND ADDITIONAL SURGICAL TOOLS WERE USED TO REMOVE THE NEEDLE FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2215357 | UNKNOWN | DYB INTRODUCER, CATHETER | DYB | COOK INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |