FGE CATHETER, BILIARY, DIAGNOSTIC
Report
- Report Number
- 3001845648-2019-00102
- Event Type
- Malfunction
- Date Received
- March 13, 2019
- Date of Event
- January 23, 2019
- Report Date
- May 8, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
EXACT RPN UNKNOWN. 5-10 K NUMBERS FOR ZILBS-635: K020788 AND K163018. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
EXACT RPN UNKNOWN. 5-10 K NUMBERS FOR ZILBS-635: K020788 AND K163018. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
EXACT RPN UNKNOWN. 5-10 K NUMBERS FOR ZILBS-635: K020788 AND K163018. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
EXACT RPN UNKNOWN. 5-10 K NUMBERS FOR ZILBS-635: K020788 AND K163018. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: THE ZILVER 635 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: N/A. DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL ZILVER 635 VASCULAR DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THERE IS EVIDENCE TO SUGGEST THE USER USED THE INCORRECT WIRE GUIDE(0.014"). THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ON THIS COMPLAINT HOWEVER THEY WERE UNSUCCESSFUL. ROOT CAUSE REVIEW FOR THE BROKEN HANDLE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PRODUCT USE OR HANDLING. THE DEVICE MAY HAVE RECEIVED EXCESSIVE PRESSURE DURING THE DEPLOYMENT PROCESS AND THE USE OF AN INCORRECT WIRE GUIDE DID NOT SUPPORT THE DEVICE. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
AS REPORTED TO CUSTOMER RELATIONS: "I¿M WRITING TO REPORT A COMPLAINT OF A HANDLE BREAKING UPON DEPLOYMENT OF A ZILVER PTX STENT. THE TECH TEXT ME THIS EVENING AND THAT¿S ALL I KNOW AT THIS POINT. I WILL GO TO THE HOSPITAL ON TUESDAY WHEN HE¿S BACK TO GET AS MANY DETAILS AS POSSIBLE. THE PATIENT IS FINE AND THEY WERE ABLE TO DEPLOY THE STENT, FROM MY UNDERSTANDING." ADDITIONAL INFORMATION PROVIDED BY DM ON 11FEB2019: "(THE CUSTOMER) MISSPOKE. THEY USED MULTIPLE STENTS DURING THE CASE AND IT WAS ACTUALLY A BARE METAL STENT NOT A ZILVER PTX." ADDITIONAL INFORMATION PROVIDED BY DM ON 12FEB2019: "THEY NO LONGER HAVE THE DEVICE. IT WAS ACCIDENTALLY TOSSED BEFORE GOING TO THEIR QUALITY CONTROL. IT WAS A ZILVER 635. THE HUB BROKE DURING DEPLOYMENT BUT THEY WERE ABLE TO DEPLOY SUCCESSFULLY WITH NO ISSUES. IT WAS THROUGH A 6X45 SHEATH AND OVER AN 014 WIRE." ADDITIONAL INFORMATION RECEIVED-ONLY DEVICE THAT MALFUNCTIONED WAS THE ZILB-635. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR BREAKING DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
AS REPORTED TO CUSTOMER RELATIONS: "I¿M WRITING TO REPORT A COMPLAINT OF A HANDLE BREAKING UPON DEPLOYMENT OF A ZILVER PTX STENT. THE TECH TEXT ME THIS EVENING AND THAT¿S ALL I KNOW AT THIS POINT. I WILL GO TO THE HOSPITAL ON TUESDAY WHEN HE¿S BACK TO GET AS MANY DETAILS AS POSSIBLE. THE PATIENT IS FINE AND THEY WERE ABLE TO DEPLOY THE STENT, FROM MY UNDERSTANDING." ADDITIONAL INFORMATION PROVIDED BY DM ON (B)(6) 2019: "(THE CUSTOMER) MISSPOKE. THEY USED MULTIPLE STENTS DURING THE CASE AND IT WAS ACTUALLY A BARE METAL STENT NOT A ZILVER PTX." ADDITIONAL INFORMATION PROVIDED BY DM ON (B)(6) 2019: "THEY NO LONGER HAVE THE DEVICE. IT WAS ACCIDENTALLY TOSSED BEFORE GOING TO THEIR QUALITY CONTROL. IT WAS A ZILVER 635. THE HUB BROKE DURING DEPLOYMENT BUT THEY WERE ABLE TO DEPLOY SUCCESSFULLY WITH NO ISSUES. IT WAS THROUGH A 6X45 SHEATH AND OVER AN 014 WIRE." ADDITIONAL INFORMATION RECEIVED-ONLY DEVICE THAT MALFUNCTIONED WAS THE ZILB-635. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR BREAKING DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
AS REPORTED TO CUSTOMER RELATIONS: "I¿M WRITING TO REPORT A COMPLAINT OF A HANDLE BREAKING UPON DEPLOYMENT OF A ZILVER PTX STENT. THE TECH TEXT ME THIS EVENING AND THAT¿S ALL I KNOW AT THIS POINT. I WILL GO TO THE HOSPITAL ON TUESDAY WHEN HE¿S BACK TO GET AS MANY DETAILS AS POSSIBLE. THE PATIENT IS FINE AND THEY WERE ABLE TO DEPLOY THE STENT, FROM MY UNDERSTANDING." ADDITIONAL INFORMATION PROVIDED BY DM ON 11FEB2019: "(THE CUSTOMER) MISSPOKE. THEY USED MULTIPLE STENTS DURING THE CASE AND IT WAS ACTUALLY A BARE METAL STENT NOT A ZILVER PTX." ADDITIONAL INFORMATION PROVIDED BY DM ON 12FEB2019: "THEY NO LONGER HAVE THE DEVICE. IT WAS ACCIDENTALLY TOSSED BEFORE GOING TO THEIR QUALITY CONTROL. IT WAS A ZILVER 635. THE HUB BROKE DURING DEPLOYMENT BUT THEY WERE ABLE TO DEPLOY SUCCESSFULLY WITH NO ISSUES. IT WAS THROUGH A 6X45 SHEATH AND OVER AN 014 WIRE." ADDITIONAL INFORMATION RECEIVED-ONLY DEVICE THAT MALFUNCTIONED WAS THE ZILB-635. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR BREAKING DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
AS REPORTED TO CUSTOMER RELATIONS: "I¿M WRITING TO REPORT A COMPLAINT OF A HANDLE BREAKING UPON DEPLOYMENT OF A ZILVER PTX STENT. THE TECH TEXT ME THIS EVENING AND THAT¿S ALL I KNOW AT THIS POINT. I WILL GO TO THE HOSPITAL ON TUESDAY WHEN HE¿S BACK TO GET AS MANY DETAILS AS POSSIBLE. THE PATIENT IS FINE AND THEY WERE ABLE TO DEPLOY THE STENT, FROM MY UNDERSTANDING." ADDITIONAL INFORMATION PROVIDED BY DM ON 11FEB2019: "(THE CUSTOMER) MISSPOKE. THEY USED MULTIPLE STENTS DURING THE CASE AND IT WAS ACTUALLY A BARE METAL STENT NOT A ZILVER PTX." ADDITIONAL INFORMATION PROVIDED BY DM ON 12FEB2019: "THEY NO LONGER HAVE THE DEVICE. IT WAS ACCIDENTALLY TOSSED BEFORE GOING TO THEIR QUALITY CONTROL. IT WAS A ZILVER 635. THE HUB BROKE DURING DEPLOYMENT BUT THEY WERE ABLE TO DEPLOY SUCCESSFULLY WITH NO ISSUES. IT WAS THROUGH A 6X45 SHEATH AND OVER AN 014 WIRE." ADDITIONAL INFORMATION RECEIVED-ONLY DEVICE THAT MALFUNCTIONED WAS THE ZILB-635. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR BREAKING DURING DEPLOYMENT (INCL. FLEXOR/HANDLE SEPARATION)¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 208848 | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |