PROWLER SELECT PLUS 150/5CM
Report
- Report Number
- 3008114965-2023-00186
- Event Type
- Malfunction
- Date Received
- April 6, 2023
- Date of Event
- March 22, 2023
- Report Date
- April 28, 2023
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- KRA
- UDI-DI
- 10886704028888
- PMA / PMN Number
- K021591
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. E.1: THE INITIAL REPORTER PHONE:(B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. H.3: THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (30946841) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00185. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED IN THE PRODUCT ANALYSIS LAB ON 20-APR-2023. THE RETURNED PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00185 AND 3008114965-2023-00186. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATION FINDING OF THE RETURNED DEVICE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. A COMPRESSED SECTION WAS NOTED ON THE MICROCATHETER AT 2 CM FROM THE DISTAL END. NO OTHER DAMAGES WERE OBSERVED. THE INNER AND OUTER DIAMETERS (ID) AND (OD) OF THE MICROCATHETER WERE MEASURED AND CONFIRMED TO BE WITHIN SPECIFICATIONS. THE MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE. AFTER FLUSHING, A LAB SAMPLE GUIDEWIRE OF 0.018-INCH (0.04572 CM) WAS INTRODUCED INTO THE MICROCATHETER AND ADVANCED. THERE WAS NO RESISTANCE OR FRICTION FELT WHEN THE GUIDEWIRE PASSED THROUGH THE PROXIMAL SECTION OF THE DEVICE. WHEN THE GUIDEWIRE GOT TO THE COMPRESSED SECTION AT 2 CM FROM THE DISTAL END AS NOTED IN THE VISUAL INSPECTION, IT GOT STUCK. THE ISSUE REGARDING THE MICROCATHETER BEING OBSTRUCTED IN THE PROXIMAL SECTION OF THE MICROCATHETER WAS NOT ABLE TO BE CONFIRMED BECAUSE THE GUIDEWIRE WAS ABLE TO PASS THROUGH THE PROXIMAL SECTION. THE ISSUE FOUND DURING THE FUNCTIONAL TEST IS NOT CONSIDERED RELATED TO THE REPORTED ISSUE AND SINCE THE MICROCATHETER DAMAGE WAS NOT ORIGINALLY REPORTED IN THE COMPLAINT, IT IS SUGGESTED THAT THIS CONDITION APPEARED DURING THE MICROCATHETER REMOVAL OR POST-OPERATIONAL HANDLING OF THE DEVICE. WITH THE EVIDENCE AVAILABLE, THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (30946841) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTION FOR USE (IFU) CONTAINS THE FOLLOWING PRECAUTION: ¿IF STRONG RESISTANCE IS MET DURING MANIPULATION, DISCONTINUE THE PROCEDURE, AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE CATHETER AND GUIDEWIRE AS A SYSTEM. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. SECTION H.6: THE CODE ¿NO DEVICE PROBLEM FOUND (C19)¿ WAS USED IN THE INVESTIGATION FINDINGS BECAUSE ISSUE REGARDING THE MICROCATHETER BEING OBSTRUCTED IN THE PROXIMAL SECTION OF THE MICROCATHETER WAS NOT ABLE TO BE CONFIRMED BECAUSE THE GUIDEWIRE WAS ABLE TO PASS THROUGH THE PROXIMAL SECTION. THE ISSUE FOUND DURING THE FUNCTIONAL TEST IS NOT CONSIDERED RELATED TO THE REPORTED ISSUE AND SINCE THE MICROCATHETER DAMAGE WAS NOT ORIGINALLY REPORTED IN THE COMPLAINT, IT IS SUGGESTED THAT THIS CONDITION APPEARED DURING THE MICROCATHETER REMOVAL OR POST-OPERATIONAL HANDLING OF THE DEVICE. THIS CODE CORRESPONDS WITH THE ¿NO PROBLEM DETECTED (D14)¿ IN THE INVESTIGATION CONCLUSION THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00185 AND 3008114965-2023-00186. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT STENT, A 4.5MM X 28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452800 / 7212912) WAS IMPEDED IN THE PROXIMAL SECTION OF THE CONCOMITANT MICROCATHETER, A 150CM X 5CM PROWLER SELECT PLUS (606S255X / 30946841) AND COULD NOT ADVANCE FURTHER AFTER SEVERAL ATTEMPTS. THE PHYSICIAN RETRACTED THE STENT AND OBSERVED THAT THE STENT COMPONENT REMAINED IN THE MICROCATHETER AND WAS NO LONGER CONNECTED TO THE DELIVERY WIRE. THE PHYSICIAN REPLACED THE STENT AND THE MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 31-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE LOCATION OF THE TARGET ANEURYSM WAS THE MIDDLE CEREBRAL ARTERY (MCA). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER DURING THE PROCEDURE. NO OTHER DEVICE WENT THROUGH THE MICROCATHETER. THERE WERE NO VISIBLE KINKS OR OTHER DAMAGES OBSERVED ON THE MICROCATHETER. THE STENT / STENT DELIVERY SYSTEM DID NOT APPEAR DAMAGED. THE REPLACEMENT STENT WAS NOT ANOTHER 4.5MM X 28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE. THE REPLACEMENT MICROCATHETER WAS ANOTHER PROWLER SELECT PLUS. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO THE ALLEGED REPORTED PRODUCT ISSUES. THE EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549141 | PROWLER SELECT PLUS 150/5CM | CATHETER, CONTINUOUS FLUSH | KRA | MEDOS INTERNATIONAL SARL | 606-S255X | 30946841 | 10886704028888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | EU ENT4.5MMD 28MML WNO DSTL TP |