EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
Report
- Report Number
- 3001845648-2019-00170
- Event Type
- Malfunction
- Date Received
- April 25, 2019
- Date of Event
- February 22, 2019
- Report Date
- May 23, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- MQR
- UDI-DI
- 10827002480381
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER
Narratives
510(K) NUMBER: K163468. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI): (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.
510(K) NUMBER: K163468. 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: ED SUTKOWSKI COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT, FILE WAS REPORTED INITIALLY BASED ON A CONSERVATIVE ASSESSMENT OF DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY¿FLEXOR KINKED/ STRETCHED/ BROKEN/ COMPRESSED¿. THE DEVICE WAS RETURNED AND EVALUATED CONFIRMING NO ISSUE WITH THE FLEXOR OF THE DEVICE. THE SHUTTLE CAP WAS FOUND TO BE BROKEN, THE FILE HAS BEEN RE-ASSESSED AND HAS AN OVERALL RISK CATEGORY IIA (LOW). THIS EVENT HAS BEEN RE-ASSESSED AND THIS REPORT IS TO NOTIFY THE FDA THAT THIS EVENT NO LONGER MEETS THE FDA REPORTING CRITERIA OF A MALFUNCTION REPORT AS PER SECTION 803.50 OF 21 CFR 803. NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510(K) NUMBER: K163468. 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.
EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR KINKED/ STRETCHED/ BROKEN/ COMPRESSED'. USER FOUND OUT THE TRIGGER OF DELIVERY SYSTEM CANNOT RELEASE STENT ANY MORE WHILE THE STENT HAS BEEN RELEASED 1/3 ALREADY. USER CANNOT PUSH THE TRIGGER ANYMORE. USER RETRACTED THE STENT INTO DELIVERY SYSTEM.
THIS FOLLOW UP MDR IS BEING SUBMITTED TO CANCEL THE INITIAL MDR. USER FOUND OUT THE TRIGGER OF DELIVERY SYSTEM CANNOT RELEASE STENT ANY MORE WHILE THE STENT HAS BEEN RELEASED 1/3 ALREADY. USER CANNOT PUSH THE TRIGGER ANYMORE. USER RETRACTED THE STENT INTO DELIVERY SYSTEM.
EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR KINKED/ STRETCHED/ BROKEN/ COMPRESSED'. USER FOUND OUT THE TRIGGER OF DELIVERY SYSTEM CANNOT RELEASE STENT ANY MORE WHILE THE STENT HAS BEEN RELEASED 1/3 ALREADY. USER CANNOT PUSH THE TRIGGER ANYMORE. USER RETRACTED THE STENT INTO DELIVERY SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342131 | EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED | MQR STENT, COLONIC METALLIC EXPANDABLE | MQR | COOK IRELAND LTD | G48038 | C1543590 | 10827002480381 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |