MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
Report
- Report Number
- 1820334-2024-01608
- Event Type
- Injury
- Date Received
- December 6, 2024
- Date of Event
- October 30, 2024
- Report Date
- May 9, 2025
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002480032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
E1: NAME AND ADDRESS = PHONE: (B)(6). G4: PMA/510(K) NUMBER = K240589. 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.
SUMMARY OF EVENT: AS REPORTED, DURING A FISTULOGRAM, A MICROPUNCTURE TRADITIONLESS STIFFENED CANNULA ACCESS SET¿S SHEATH WAS INADVERTENTLY/ACCIDENTALLY TRANSECTED/CUT BY THE USER. PER THE REPORTER, THE FISTULA HAD BEEN EXTENSIVELY STENTED AT ANOTHER FACILITY, EXCEPT FOR APPROXIMATELY ONE CENTIMETER OF THE MID-FISTULA, WHICH IS WHERE ACCESS WAS OBTAINED FOR THE FISTULOGRAM. THE FISTULOGRAM SHOWED NARROWING OF THE STENTS. THE PATIENT HAD SEVERE ULNAR DISEASE, AND THE MAIN FLOW TO THE HAND WAS THE RADIAL ARTERY. SEVERE ¿STEAL¿ WAS NOTED DUE TO THE FISTULA. REPORTEDLY, THERE WAS NO OPTION FOR PLICATION, AS THE FISTULA WAS EXTENSIVELY STENTED, AND PATENCY OF THE FISTULA WAS ALSO POOR DUE TO THE EXTENT OF STENTING. THEREFORE, THE USER DECIDED TO LIGATE THE FISTULA. PER THE REPORTER, THE ONLY AREA TO LIGATE WAS WITHIN THE SAME AREA AS THE ACCESS SITE, WHERE THE COMPLAINT DEVICE WAS LOCATED. DURING DISSECTION OF THE TISSUES, BLEEDING WAS REPORTED. AS THE USER DISSECTED TO GAIN CONTROL OF THE BLEEDING, THE SHEATH WAS INADVERTENTLY TRANSECTED. THE USER WAS UNABLE TO LOCATE THE DISTAL TIP OF THE SHEATH. AN ULTRASOUND OF THE ARM WAS PERFORMED, AS WELL AS INTRAVENOUS ULTRASOUND, TRANSESOPHAGEAL ECHOCARDIOGRAM, AND PULMONARY ARTERIOGRAM; HOWEVER, THE FRAGMENT WAS NOT LOCATED. THE NEXT DAY, THE PATIENT DEVELOPED A PULMONARY ARTERY EMBOLISM DUE TO THE FOREIGN BODY. AN INTERVENTIONAL PULMONARY ARTERIOGRAM WAS PERFORMED, FINDING THE SHEATH FRAGMENT IN THE LEFT LOWER LUNG. THE FRAGMENT WAS UNABLE TO BE RETRIEVED WITH A SUCTION THROMBECTOMY CATHETER; HOWEVER, A SNARE WAS USED TO SUCCESSFULLY REMOVE THE FRAGMENT IN ITS ENTIRETY. PER THE REPORTER, THE PHYSICIAN DOES NOT FEEL THAT THERE WAS ANYTHING WRONG WITH THE DEVICE, AS IT WAS ACCIDENTALLY CUT DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED 11DEC2024. THE LIGATION WAS COMPLETED SUCCESSFULLY. PER THE REPORTER, THERE WAS NO CONCERN WITH DEVICE FUNCTIONALITY. CORRECTED INFORMATION: H6 (ANNEX A). INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE OUTER CATHETER HAD BEEN CUT APPROXIMATELY 3.8-CENTIMETERS FROM THE HUB. THE DISTAL PORTION OF THE CATHETER MEASURED APPROXIMATELY 5.5-CENTIMETERS IN LENGTH. THE DISTAL TIP WAS BUNCHED AND OUT OF ROUND. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE 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 PROCEDURAL ISSUES CONTRIBUTED TO THIS EVENT. DURING LIGATION OF THE FISTULA AND DISSECTION OF TISSUES IN THE SAME ONE-CENTIMETER AREA AS THE SHEATH/OUTER CATHETER, THE DEVICE WAS ACCIDENTALLY CUT BY THE USER DURING ATTEMPTS TO CONTROL BLEEDING. THE RISK ANALYSIS 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. 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.
AS REPORTED, DURING A FISTULAGRAM, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET¿S SHEATH WAS INADVERTENTLY/ACCIDENTALLY TRANSECTED/CUT BY THE USER. PER THE REPORTER, THE FISTULA HAD BEEN EXTENSIVELY STENTED AT ANOTHER FACILITY, EXCEPT FOR APPROXIMATELY ONE CENTIMETER OF THE MID-FISTULA, WHICH IS WHERE ACCESS WAS OBTAINED FOR THE FISTULAGRAM. THE FISTULAGRAM SHOWED NARROWING OF THE STENTS. THE PATIENT HAD SEVERE ULNAR DISEASE, AND THE MAIN FLOW TO THE HAND WAS THE RADIAL ARTERY. SEVERE ¿STEAL¿ WAS NOTED DUE TO THE FISTULA. REPORTEDLY, THERE WAS NO OPTION FOR PLICATION, AS THE FISTULA WAS EXTENSIVELY STENTED, AND PATENCY OF THE FISTULA WAS ALSO POOR DUE TO THE EXTENT OF STENTING. THEREFORE, THE USER DECIDED TO LIGATE THE FISTULA. PER THE REPORTER, THE ONLY AREA TO LIGATE WAS WITHIN THE SAME AREA AS THE ACCESS SITE, WHERE THE COMPLAINT DEVICE WAS LOCATED. DURING DISSECTION OF THE TISSUES, BLEEDING WAS REPORTED. AS THE USER DISSECTED TO GAIN CONTROL OF THE BLEEDING, THE SHEATH WAS INADVERTENTLY TRANSECTED. THE USER WAS UNABLE TO LOCATE THE DISTAL TIP OF THE SHEATH. AN ULTRASOUND OF THE ARM WAS PERFORMED, AS WELL AS INTRAVENOUS ULTRASOUND, TRANSESOPHAGEAL ECHOCARDIOGRAM, AND PULMONARY ARTERIOGRAM; HOWEVER, THE FRAGMENT WAS NOT LOCATED. THE NEXT DAY, THE PATIENT DEVELOPED A PULMONARY ARTERY EMBOLISM DUE TO THE FOREIGN BODY. AN INTERVENTIONAL PULMONARY ARTERIOGRAM WAS PERFORMED, FINDING THE SHEATH FRAGMENT IN THE LEFT LOWER LUNG. THE FRAGMENT WAS UNABLE TO BE RETRIEVED WITH A SUCTION THROMBECTOMY CATHETER; HOWEVER, A SNARE WAS USED TO SUCCESSFULLY REMOVE THE FRAGMENT IN ITS ENTIRETY. PER THE REPORTER, THE PHYSICIAN DOES NOT FEEL THAT THERE WAS ANYTHING WRONG WITH THE DEVICE, AS IT WAS ACCIDENTALLY CUT DURING THE PROCEDURE.
ADDITIONAL INFORMATION WAS RECEIVED 11DEC2024. THE LIGATION WAS COMPLETED SUCCESSFULLY. PER THE REPORTER, THERE WAS NO CONCERN WITH DEVICE FUNCTIONALITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2078152 | MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET | DYB INTRODUCER, CATHETER | DYB | COOK INC | G48003 | 16190505 | 00827002480032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female | Other| R |