SPIDERFX EMBOLIC PROTECTION DEVICE
Report
- Report Number
- 2183870-2014-00096
- Event Type
- Injury
- Date Received
- May 15, 2014
- Date of Event
- April 15, 2014
- Report Date
- April 16, 2014
- Manufacturer
- COVIDIEN
- Product Code
- NTE
- PMA / PMN Number
- K111010
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. IMAGE OF DEPLOYED SPIDER RECEIVED.
THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.
THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FO LLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.
THE PHYSICIAN STATED THAT THE GUIDEWIRE ON THE TIP OF THE PROTECTIVE UMBRELLA WAS BROKEN. SURGERY TIME WAS EXTENDED BY MORE THAN 30MINS DUE TO THE PRODUCT PROBLEM. NOTHING EMBOLIZED IN THE PATIENT AND THE PATIENT IS IN GOOD CONDITION.
A COMPACT DISC WITH SEVERAL CINE IMAGES (IN ONE "PLAY-LOOP") WAS RECEIVED FOR EVALUATION. THE IMAGES DOCUMENT THE USE OF A SPIDER FX DEVICE IN A CAROTID STENTING PROCEDURE AND THE ATTEMPTED CAPTURE OF AN EMBOLIZED FRAGMENT (NOT IDENTIFIED). THE RESOLUTION OF THE IMAGES WAS NOT ADEQUATE TO DETERMINE THE FULL SCENARIO OF EVENTS. THERE APPEARS TO BE A CINE SERIES THAT DOCUMENTS THE RETRIEVAL OF DEVICE (POSSIBLY THE SPIDER FX FILTER) THROUGH THE DEPLOYED STENT. THE SPIDERFX EMBOLIC PROTECTION DEVICE WAS RECEIVED FOR EVALUATION WITHOUT ANY ANCILLARY DEVICES OR CINE IMAGES FROM THE PROCEDURE. THE SPIDER WAS RETURNED IN ITS TRANSPORTATION HOOP PACKED ALONG WITH ITS POUCH WITHIN ITS SHELF CARTON. THE FILTER EXTENDED OUT OF THE HOOP AND THE DISTAL FLOPPY TIP EXHIBITED A KINK FRACTURE PROXIMAL TO THE ADHESIVE FILLET AND WELD. PER RESPONSES AFTER THE INITIAL REPORT THE TIP WAS NOTED AS MISSING WHEN THE SPIDER FILTER WAS RETRIEVED. THE DISTAL FLOPPY TIP ON THE RETURNED SPIDER WAS MISSING. THE WIRE DISTAL TO THE FILTER EXHIBITED A KINK FRACTURE FACE PROXIMAL TO THE DISTAL FLOPPY TIP ADHESIVE FILLET AND WELD.
A COMPACT DISC WITH SEVERAL CINE IMAGES (IN ONE "PLAY-LOOP") WAS RECEIVED FOR EVALUATION. THE IMAGES DOCUMENT THE USE OF A SPIDER FX DEVICE IN A CAROTID STENTING PROCEDURE AND THE ATTEMPTED CAPTURE OF AN EMBOLIZED FRAGMENT (NOT IDENTIFIED). THE RESOLUTION OF THE IMAGES WAS NOT ADEQUATE TO DETERMINE THE FULL SCENARIO OF EVENTS. THERE APPEARS TO BE A CINE SERIES THAT DOCUMENTS THE RETRIEVAL OF DEVICE (POSSIBLY THE SPIDER FX FILTER) THROUGH THE DEPLOYED STENT. THE SPIDERFX EMBOLIC PROTECTION DEVICE WAS RECEIVED FOR EVALUATION WITHOUT ANY ANCILLARY DEVICES OR CINE IMAGES FROM THE PROCEDURE. THE SPIDER WAS RETURNED IN ITS TRANSPORTATION HOOP PACKED ALONG WITH ITS POUCH WITHIN ITS SHELF CARTON. THE FILTER EXTENDED OUT OF THE HOOP AND THE DISTAL FLOPPY TIP EXHIBITED A KINK FRACTURE PROXIMAL TO THE ADHESIVE FILLET AND WELD. PER RESPONSES AFTER THE INITIAL REPORT THE TIP WAS NOTED AS MISSING WHEN THE SPIDER FILTER WAS RETRIEVED. THE DISTAL FLOPPY TIP ON THE RETURNED SPIDER WAS MISSING. THE WIRE DISTAL TO THE FILTER EXHIBITED A KINK FRACTURE FACE PROXIMAL TO THE DISTAL FLOPPY TIP ADHESIVE FILLET AND WELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289995 | SPIDERFX EMBOLIC PROTECTION DEVICE | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE | NTE | COVIDIEN | SPD2-040-320 | 9675601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other| R |