CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
Report
- Report Number
- 2029046-2024-01266
- Event Type
- Malfunction
- Date Received
- April 16, 2024
- Date of Event
- March 20, 2024
- Report Date
- September 4, 2024
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- DYB
- PMA / PMN Number
- K170997
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
G1. MANUFACTURING SITE. IS FREUDENBERG MEDICAL LLC, THEREFORE G1 MANUFACTURING SITE DETAILS HAVE BEEN UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
CORRECTION: FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. ON 02-JUL-2024, MEDWATCH REPORT (B)(4) WAS RECEIVED BY BIOSENSE WESBTER, INC. AND IT WAS DETERMINED TO BE THE SAME EVENT AS WHAT HAS ALREADY BEEN REPORTED UNDER 2029046-2024-01266. HOWEVER, NEW INFORMATION WAS PRESENTED ON MEDWATCH REPORT (B)(4) WHERE IT WAS INDICATED THAT A FOREIGN BODY WAS PRESENT IN THE CLEAR HUB ON VIZIGO. THEREFORE, H6. MEDICAL DEVICE PROBLEM CODE HAS BEEN UPDATED AND THE CODE OF ¿CONTAMINATION / DECONTAMINATION PROBLEM (A18)¿ HAS BEEN ADDED. ON 25-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS INDICATED THAT THE ISSUE WAS NOTED DURING USE OF THE DEVICE. THE PATIENT DETAILS WERE PROVIDED AND THEREFORE, SECTION A. PATIENT INFORMATION WAS UPDATED. GENERATOR INFORMATION WAS PROVIDED AND THEREFORE, THE CONCOMITANT PRODUCT SECTION WAS UPDATED. WITH THE ADDITIONAL INFORMATION, THE DEVICE EVALUATION HAS BEEN UPDATED AS FOLLOWS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO FOREIGN MATERIAL IN THE HUB AREA; HOWEVER, THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF HUB COMPONENT, AND TWO HOLES IN THE UNION BETWEEN THE HUB AND SIDE PORT TUBE WERE OBSERVED. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER. THE DAMAGE OBSERVED COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT OF THE VALVE; THE STRESS MARKS AND PHYSICAL DAMAGE OBSERVED SUGGEST THAT EXCESSIVE FORCE OR MANIPULATION WAS APPLIED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 60000308 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE HOLES OBSERVED IN THE ADHESIVE OF THE UNION OF THE SIDE PORT TUBE AND HUB COULD BE RELATED TO THE HUB BROKEN ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE REPORTED FOREIGN MATERIAL ON THE HUB COULD NOT BE CONFIRMED DURING THE PRODUCT INVESTIGATION. THE HUB FAILURE IS RELATED TO THE MANUFACTURING PROCESS. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) CONTAINS THE FOLLOWING CAUTION: ALWAYS INSERT A DILATOR STRAIGHT INTO THE CENTER OF THE SHEATH¿S VALVE TO PREVENT DAMAGE TO THE VALVE. DO NOT INSERT A DILATOR AT AN ANGLE, AS DAMAGE TO THE SHEATH VALVE MAY OCCUR. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ADHESIVE ISSUES. EXPLANATION OF CODES: INVESTIGATION FINDINGS: MANUFACTURING PROCESS PROBLEM IDENTIFIED (C16) / INVESTIGATION CONCLUSIONS: NO CAUSE TRACED TO MANUFACTURING (D03) / COMPONENT CODE: ADHESIVE (G0405201) WERE SELECTED AS RELATED TO THE ADHESIVE ISSUE THAT WAS NOTED DURING THE INVESTIGATION FINDINGS: FRACTURE PROBLEM (C070603) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO MANUFACTURING (D03) / COMPONENT CODE: ADHESIVE (G0405201) WERE SELECTED AS RELATED TO THE HUB BROKEN ISSUE INVESTIGATION FINDINGS: FRACTURE PROBLEM (C070603) / INVESTIGATION CONCLUSIONS: UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT (D1102)) / COMPONENT CODE: VALVE(S) (G04135) WERE SELECTED AS RELATED TO THE HEMOSTATIC VALVE THAT WAS DISLODGED INSIDE OF HUB COMPONENT INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19) / INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE REPORTED FOREIGN BODY WAS PRESENT IN THE CLEAR HUB ON VIZIGO IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).
CORRECTION TO FOLLOW UP REPORT #2 (RECORD ID - (B)(4). THE RELATED REPORT NUMBER OF (B)(4) HAS BEEN ADDED IN THE CORRESPONDING BLOCK H10, RELATED REPORT NUMBER FIELD. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND THE VIZIGO¿ SHEATH HAD A CRACKED HUB. THE SHEATH WAS EXCHANGED FOR ANOTHER VIZIGO¿ TO CONTINUE THE CASE SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF HUB COMPONENT, AND TWO HOLES IN THE UNION BETWEEN THE HUB AND SIDEPORT TUBE WAS OBSERVED. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER. THE DAMAGE OBSERVED COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT OF THE VALVE. THE STRESS MARKS AND PHYSICAL DAMAGE OBSERVED SUGGEST THAT EXCESSIVE FORCE OR MANIPULATION WAS APPLIED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 60000308 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED SINCE THE HOLES OBSERVED IN THE ADHESIVE OF THE UNION OF THE SIDEPORT TUBE AND HUB COULD BE RELATED TO THE HUB ISSUE REPORTED BY THE CUSTOMER. THE HUB FAILURE IS RELATED TO THE MANUFACTURING PROCESS. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) CONTAINS THE FOLLOWING CAUTION: ALWAYS INSERT A DILATOR STRAIGHT INTO THE CENTER OF THE SHEATH¿S VALVE TO PREVENT DAMAGE TO THE VALVE. DO NOT INSERT A DILATOR AT AN ANGLE, AS DAMAGE TO THE SHEATH VALVE MAY OCCUR. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ADHESIVE ISSUES. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND THE VIZIGO¿ SHEATH HAD A CRACKED HUB. THE SHEATH WAS EXCHANGED FOR ANOTHER VIZIGO¿ TO CONTINUE THE CASE SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1800779 | CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM | INTRODUCER, CATHETER | DYB | BIOSENSE WEBSTER INC | 60000308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | BRK 1 TRANSSEPTAL NEEDLE.| UNK_NGEN RF GENERATOR. |