MICROPUNCTURE TRANSITIONLESS ACCESS SET
Report
- Report Number
- 1820334-2020-00320
- Event Type
- Injury
- Date Received
- February 10, 2020
- Date of Event
- January 30, 2020
- Report Date
- August 5, 2020
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002438699
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
SUMMARY OF EVENT: AS REPORTED, THE HUB OF A MICROPUNCTURE TRANSITIONLESS ACCESS SET CATHETER, WHICH WAS USED FOR MONITORING OF ARTERIAL PRESSURE DURING A PROCEDURE INVOLVING SURGICAL REMOVAL OF A NECROTIC PENIS, SEPARATED AS THE WIRE GUIDE AS REMOVED. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, TYPE II DIABETES, ATHEROSCLEROSIS, AN ISCHEMIC MYOCARDIAL INFARCTION, AORTIC STRICTURE, KIDNEY DISEASE WITH ANURIA, AND EXTREME CALCIFICATION OF THE ARTERIES. THE PATIENT'S BODY MASS INDEX WAS REPORTEDLY OVER 40 KG/MM2. THE ANESTHESIOLOGIST HAD REPORTEDLY ATTEMPTED VASCULAR ACCESS WITH OTHER UNKNOWN MANUFACTURERS' DEVICES BUT WAS UNSUCCESSFUL. THE EXTREMELY SEVERE CALCIFIED ARTERIES AND CALCIFIED ACCESS SITES CAUSED DIFFICULTY ACCESSING THE VESSELS AND FEEDING THE GUIDE WIRE. THE USER THEN GAINED ACCESS IN THE RIGHT BRACHIAL ARTERY WITH THE COMPLAINT DEVICE, USING ULTRASOUND GUIDANCE. THIS ACCESS SITE WAS NOT REPORTED TO BE CALCIFIED OR SCARRED, AND RESISTANCE WAS NOT ENCOUNTERED. THE USER REPORTED THAT PLACEMENT WAS SMOOTH AND THE WIRE WAS MOBILE THROUGHOUT THE PLACEMENT PROCESS. AS THE USER REMOVED THE WIRE GUIDE FROM THE CATHETER, THE HUB SEPARATED. THE INTRODUCER REMAINED INTACT. PER THE USER, NO PORTION OF THE CATHETER REMAINED IN THE HUB. THE PATIENT DEVELOPED A HEMATOMA AT THE INSERTION SITE AND THE USER WAS UNSURE IF THE CATHETER HAD REMAINED IN THE PATIENT'S ARM. A VASCULAR CONSULT WAS OBTAINED TO EXPLORE THE ARM FOR THE SEPARATED PORTION OF THE CATHETER. THE PATIENT IMMEDIATELY UNDERWENT SURGICAL EXPLORATION OF THE BRACHIAL ARTERY UNDER GENERAL ANESTHESIA, HOWEVER, NO CATHETER WAS FOUND. THE VASCULAR SURGEONS CONCLUDED THAT THE CATHETER WAS NOT IN THE ARTERY AND IT WAS ALSO NOT FELT IN THE SOFT TISSUE. STAFF INSPECTED THE AREA AROUND THE PATIENT, INCLUDING THE FLOOR, BUT DID NOT FIND THE CATHETER. THE USER IS UNABLE TO CONFIRM IF THE CATHETER WAS ORIGINALLY CONNECTED TO THE HUB, AS THE CATHETER AND INTRODUCER ARE BOTH GRAY. IT IS UNKNOWN WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE; HOWEVER, THE USER CONFIRMED THAT THE PATIENT CONTINUED TO DO "WELL" THE DAY AFTER SURGERY. ADDITIONAL INFORMATION WAS RECEIVED 12FEB2020. CANNULATION OF THE ARTERY WAS "REMARKABLY" DIFFICULT, WITH MULTIPLE ANESTHESIOLOGISTS AND MULTIPLE METHODS UTILIZED. ALL ATTEMPTS AT ARTERIAL ACCESS HAD BEEN UNSUCCESSFUL PRIOR TO GAINING ACCESS IN THE BRACHIAL ARTERY WITH THE COMPLAINT DEVICE. AFTER THE NEEDLE AND INTRODUCER WERE INSERTED INTO THE BRACHIAL ARTERY, THE SHEATH WAS NOT RETRIEVED. THE 77 YEAR-OLD PATIENT, WHO WAS ALREADY UNDER ANESTHESIA FOR THE ORIGINAL INTENDED PROCEDURE, DEVELOPED AN EXPANDING HEMATOMA IN THE ARM. THE RIGHT UPPER EXTREMITY WAS DRAPED AND PREPPED AND A SURGICAL DISSECTION OF THE RIGHT BRACHIAL ARTERY WAS PERFORMED. THE ARTERY WAS CLAMPED PROXIMALLY AND DISTALLY AFTER HEPARINIZING THE PATIENT AND AN 11-BLADE WAS USED TO PERFORM AN ARTERIOTOMY WITH SCISSORS. NO SHEATH WAS FOUND IN THE ARTERY. THE BLEEDING ARTERIAL LINE PUNCTURE SITE WAS REPAIRED USING INTERRUPTED SUTURES AND THE ARTERY WAS REPAIRED USING RUNNING SUTURES. THE SURROUNDING MUSCLE AND TISSUE WERE EXAMINED AS WELL; HOWEVER, THE MISSING SHEATH WAS NOT FOUND. THE PULSE WAS PALPABLE PROXIMALLY AND DISTALLY TO THE REPAIR LINE. AN ULNAR SIGNAL WAS PRESENT AT THE COMPLETION OF THE PROCEDURE. THE INCISION WAS CLOSED WITH INTERRUPTED SUTURE IN A MATTRESS FASHION. FIBRILLAR WAS USED FOR HEMOSTASIS AND WAS LEFT IN THE WOUND BED. A STERILE DRESSING WAS APPLIED AND THE ORIGINAL INTENDED PROCEDURE CONTINUED AS PLANNED. THE MISSING SHEATH WAS NOT FOUND. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. EVALUATION OF THE COMPLAINT DEVICE FOUND THAT THE DEVICE WAS USED, WITH BIOMATTER PRESENT. THE INNER CATHETER WITH THE OUTER CATHETER HUB ATTACHED WAS RETURNED. THE OUTER CATHETER SHAFT WAS NOT RETURNED. NO CATHETER MATERIAL REMAINED INSIDE THE HUB. THE INNER CATHETER WAS BOWED. NO OTHER ISSUES WERE IDENTIFIED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. COOK REVIEWED THE DEVICE MASTER RECORD OF THE COMPLAINT DEVICE INCLUDING THE MANUFACTURING INSTRUCTION, QUALITY CONTROL PROCEDURES, TECHNICAL FILE, AND INSTRUCTIONS FOR USE. IT WAS CONCLUDED THAT THERE ARE SUFFICIENT CONTROLS IN PLACE TO PREVENT THIS ISSUE FROM OCCURRING. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE OUTER CATHETER AND HUB ARE MANUFACTURED AND BONDED TOGETHER AT APPROVED VENDOR. COOK REQUESTED THAT THE SUPPLIER INVESTIGATE THIS OCCURRENCE. THE SUPPLIER CONCLUDED THAT THE FAILURE MOST LIKELY OCCURRED AS A RESULT OF OPERATOR ERROR DURING MANUFACTURING. IN RESPONSE TO THIS EVENT, THE SUPPLIER HAS CARRIED OUT DEFECT AWARENESS TRAINING WITH THE INSERT MOLDING OPERATORS TO EMPHASIZE THE IMPORTANCE OF PROPER TUBE PLACEMENT, AND THE VISUAL INSPECTION REQUIREMENTS TO ENSURE THAT THE TUBE IS CORRECTLY LOCATED WITHIN THE HUB. BASED ON THE SUPPLIER INVESTIGATION, THE MOST LIKELY CAUSE FOR THIS INCIDENT IS MANUFACTURING RELATED; HOWEVER, IT IS BELIEVED TO BE ISOLATED TO A SINGLE UNIT. THERE IS NO EVIDENCE OF ADDITIONAL NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN-HOUSE OR IN THE FIELD. DEFECT AWARENESS TRAINING HAS BEEN CONDUCTED AT THE SUPPLIER¿S MANUFACTURING FACILITY IN RESPONSE TO THIS COMPLAINT. 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 OR UNAVAILABLE. ADDITIONAL INFORMATION: A2, B5, D10/H3 A2: THE PATIENT'S AGE WAS ORIGINALLY REPORTED AS 78, NEW INFORMATION STATES THAT THE PATIENT IS 77. B5: DESCRIPTION OF EVENT UPDATED. D10/H3: 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION WAS RECEIVED 12FEB2020. CANNULATION OF THE ARTERY WAS "REMARKABLY" DIFFICULT , WITH MULTIPLE ANESTHESIOLOGISTS AND MULTIPLE METHODS UTILIZED. ALL ATTEMPTS AT ARTERIAL ACCESS HAD BEEN UNSUCCESSFUL PRIOR TO GAINING ACCESS IN THE BRACHIAL ARTERY WITH THE COMPLAINT DEVICE. AFTER THE NEEDLE AND INTRODUCER WERE INSERTED INTO THE BRACHIAL ARTERY, THE SHEATH WAS NOT RETRIEVED. THE 77 YEAR-OLD PATIENT , WHO WAS ALREADY UNDER ANESTHESIA FOR THE ORIGINAL INTENDED PROCEDURE, DEVELOPED AN EXPANDING HEMATOMA IN THE ARM. THE RIGHT UPPER EXTREMITY WAS DRAPED AND PREPPED AND A SURGICAL DISSECTION OF THE RIGHT BRACHIAL ARTERY WAS PERFORMED. THE ARTERY WAS CLAMPED PROXIMALLY AND DISTALLY AFTER HEPARINIZING THE PATIENT AND AN 11-BLADE WAS USED TO PERFORM AN ARTERIOTOMY WITH SCISSORS. NO SHEATH WAS FOUND IN THE ARTERY. THE BLEEDING ARTERIAL LINE PUNCTURE SITE WAS REPAIRED USING INTERRUPTED SUTURES AND THE ARTERY WAS REPAIRED USING RUNNING SUTURES. THE SURROUNDING MUSCLE AND TISSUE WERE EXAMINED AS WELL; HOWEVER, THE MISSING SHEATH WAS NOT FOUND. THE PULSE WAS PALPABLE PROXIMALLY AND DISTALLY TO THE REPAIR LINE. AN ULNAR SIGNAL WAS PRESENT AT THE COMPLETION OF THE PROCEDURE. THE INCISION WAS CLOSED WITH INTERRUPTED SUTURE IN A MATTRESS FASHION. FIBRILLAR WAS USED FOR HEMOSTASIS AND WAS LEFT IN THE WOUND BED. A STERILE DRESSING WAS APPLIED AND THE ORIGINAL INTENDED PROCEDURE CONTINUED AS PLANNED. THE MISSING SHEATH WAS NOT FOUND.
PER THE INITIAL REPORTER, IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. PMA/510(K) NUMBER = K171275. (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, THE HUB OF A MICROPUNCTURE TRANSITIONLESS ACCESS SET CATHETER, WHICH WAS USED FOR MONITORING OF ARTERIAL PRESSURE DURING A PROCEDURE INVOLVING SURGICAL REMOVAL OF A NECROTIC PENIS, SEPARATED AS THE WIRE GUIDE AS REMOVED. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, TYPE II DIABETES, ATHEROSCLEROSIS, AN ISCHEMIC MYOCARDIAL INFARCTION, AORTIC STRICTURE, KIDNEY DISEASE WITH ANURIA, AND EXTREME CALCIFICATION OF THE ARTERIES. THE PATIENT'S BODY MASS INDEX WAS REPORTEDLY OVER 40 KG/MM2. THE ANESTHESIOLOGIST HAD REPORTEDLY ATTEMPTED VASCULAR ACCESS WITH OTHER UNKNOWN MANUFACTURERS' DEVICES BUT WAS UNSUCCESSFUL. THE EXTREMELY SEVERE CALCIFIED ARTERIES AND CALCIFIED ACCESS SITES CAUSED DIFFICULTY ACCESSING THE VESSELS AND FEEDING THE GUIDE WIRE. THE USER THEN GAINED ACCESS IN THE RIGHT BRACHIAL ARTERY WITH THE COMPLAINT DEVICE, USING ULTRASOUND GUIDANCE. THIS ACCESS SITE WAS NOT REPORTED TO BE CALCIFIED OR SCARRED, AND RESISTANCE WAS NOT ENCOUNTERED. THE USER REPORTED THAT PLACEMENT WAS SMOOTH AND THE WIRE WAS MOBILE THROUGHOUT THE PLACEMENT PROCESS. AS THE USER REMOVED THE WIRE GUIDE FROM THE CATHETER, THE HUB SEPARATED. THE INTRODUCER REMAINED INTACT. PER THE USER, NO PORTION OF THE CATHETER REMAINED IN THE HUB. THE PATIENT DEVELOPED A HEMATOMA AT THE INSERTION SITE AND THE USER WAS UNSURE IF THE CATHETER HAD REMAINED IN THE PATIENT'S ARM. A VASCULAR CONSULT WAS OBTAINED TO EXPLORE THE ARM FOR THE SEPARATED PORTION OF THE CATHETER. THE PATIENT IMMEDIATELY UNDERWENT SURGICAL EXPLORATION OF THE BRACHIAL ARTERY UNDER GENERAL ANESTHESIA, HOWEVER, NO CATHETER WAS FOUND. THE VASCULAR SURGEONS CONCLUDED THAT THE CATHETER WAS NOT IN THE ARTERY AND IT WAS ALSO NOT FELT IN THE SOFT TISSUE. STAFF INSPECTED THE AREA AROUND THE PATIENT, INCLUDING THE FLOOR, BUT DID NOT FIND THE CATHETER. THE USER IS UNABLE TO CONFIRM IF THE CATHETER WAS ORIGINALLY CONNECTED TO THE HUB, AS THE CATHETER AND INTRODUCER ARE BOTH GRAY. IT IS UNKNOWN WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE; HOWEVER, THE USER CONFIRMED THAT THE PATIENT CONTINUED TO DO "WELL" THE DAY AFTER SURGERY. 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 |
|---|---|---|---|---|---|---|---|
| 150704 | MICROPUNCTURE TRANSITIONLESS ACCESS SET | DYB INTRODUCER, CATHETER | DYB | COOK INC | G43869 | 10161672 | 00827002438699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |