INDY OTW VASCULAR RETRIEVER
Report
- Report Number
- 1820334-2016-01301
- Event Type
- Malfunction
- Date Received
- October 24, 2016
- Report Date
- July 11, 2017
- Manufacturer
- COOK INC
- Product Code
- MMX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). 510(K) #: K160593. PRODUCT WAS RECEIVED BY THE MANUFACTURER AS AN UNAUTHORIZED REPAIR WITH NO INFORMATION. ON-GOING INVESTIGATION AND ADDITIONAL REVIEW BY THE REGULATORY REPORTING GROUP HAS DETERMINED THIS EVENT TO A REPORTABLE MALFUNCTION. THE EVENT IS CURRENTLY UNDER INVESTIGATION.
INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE ENTIRE INDY OVER-THE- WIRE (OTW) VASCULAR RETRIEVER WAS RETURNED FOR EVALUATION WITH THE SNARE INSIDE OF THE OUTER SHEATH. THE INNER CATHETER IS KINKED IN MULTIPLE LOCATIONS. THIS MAY BE DUE TO THE FACT THAT IT WAS FOLDED IN THE BAG. THE HUB IS COVERED IN BLOOD AND HAS BIO-MATTER IN THE LUMEN. TUOHY-BORST CONNECTOR IS COVERED IN BLOOD. OUTER CATHETER IS SEPARATED 6.8CM FROM THE HUB. THE COIL IS STILL ATTACHED TO BOTH SIDES. THE DISTAL SECTION OF THE OUTER CATHETER IS 93.2CM LONG. IT IS KINKED 9CM AND 26CM FROM THE DISTAL TIP. THE DISTAL TIP IS COVERED IN BIO-MATTER. THE INNER LINER IS TORN/SHREDDED AND HAS MULTIPLE PIECES TANGLED WITHIN THE EXPOSED COIL. NUMBER OF COILS PER 3/8 INCH WERE COUNTED JUST PROXIMAL TO THE SEPARATION SITE AND FOUND TO BE WITHIN SPECIFICATION. WHEN THE TUOHY-BORST WAS LOOSENED ALL OF THE WAY, THE INNER CATHETER REMAINED STUCK WITH NORMAL PULLING FORCE. THE INNER CATHETER SLIDES FREELY THROUGH THE PROXIMAL PORTION OF THE OUTER CATHETER. THEREFORE IT IS STUCK SOMEWHERE IN THE DISTAL PORTION. THE INNER CATHETER COULD NOT BE REMOVED WITH FORCEFUL EFFORT. THE INNER CATHETER WAS FLUSHED WITH WATER BUT CATHETER STILL COULD NOT BE REMOVED. THE HUB WAS SLIGHTLY LOOSE (PERHAPS FROM PULLING ON IT) SO NOT MUCH WATER COULD BE FLUSHED. AN OBJECT IS VISIBLE THROUGH THE LUMEN OF THE DISTAL TIP AT THE MARKER BAND. AFTER CUTTING OPEN THE DISTAL END OF THE CATHETER, IT BECAME EVIDENT THAT THE VISIBLE OBJECT WAS THE LINER OF THE CATHETER THAT HAD BECOME DETACHED. THE CATHETER WAS TRANSVERSELY CUT AT THE POINT OF THE SNARE AND ONE OF THE SNARE LOOPS WAS FOUND TO BE BENT BACKWARDS. AFTER THE SNARE WAS OPENED AND THEN CLOSED AGAIN, THE INNER CATHETER WAS ABLE TO BE REMOVED. THERE WAS NOTHING IN THE SNARE. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. INFORMATION PROVIDED INDICATES THAT THE IVC FILTER REMOVAL WAS DIFFICULT AND THAT THE FILTER HAD A BROKEN STRUT AND BENT HOOK UPON REMOVAL. THE DEFORMED FILTER POTENTIALLY CREATED EXCESSIVE RESISTANCE BETWEEN THE SNARE AND THE SHEATH, WHICH COULD HAVE LED TO THE SHEATH FRACTURE. ADDITIONALLY, IF THE TUOHY-BORST WAS NOT PROPERLY TIGHTENED PRIOR TO REMOVAL, PULLING BACK ON THE SHEATH MAY HAVE RESULTED IN SHEATH SEPARATION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT ,NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.
(B)(4). PRODUCT WAS RECEIVED BY THE MANUFACTURER AS AN UNAUTHORIZED REPAIR WITH NO INFORMATION. ON-GOING INVESTIGATION AND ADDITIONAL REVIEW BY THE REGULATORY REPORTING GROUP HAS DETERMINED THIS EVENT TO A REPORTABLE MALFUNCTION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE EVENT OR PATIENT INFORMATION A FOLLOW-UP REPORT WILL BE GENERATED. THE EVENT IS CURRENTLY UNDER INVESTIGATION.
THE INITIAL INFORMATION PROVIDED STATED ONLY THAT THE SHEATH MATERIAL SEPARATED. THIS DEVICE WAS RETURNED, ALONG WITH SEVERAL OTHER DEVICES, WITH NO IDENTIFICATION, RETURN AUTHORIZATION OR DETAILS OF AN EVENT. SEVERAL ATTEMPTS WERE MADE TO DETERMINE ADDITIONAL INFORMATION REGARDING THE RETURNED UNMARKED PRODUCTS. DURING THE VISUAL INSPECTION, IT WAS NOTED THERE WAS SHEATH MATERIAL SEPARATION; WITH THE COIL REMAINING INTACT. THE EVENT WAS DETERMINED TO BE REPORTABLE AT THAT TIME AND ATTEMPTS TO GATHER ADDITIONAL INFORMATION CONCERNING THE NATURE AND DETAILS OF THE EVENT. ON (B)(6) 2016, THE PRODUCT IDENTIFIER, CUSTOMER ENTITY AND CUSTOMER PERSON WERE IDENTIFIED. NO INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME OR FURTHER DETAILS OF THE EVENT.
IT WAS REPORTED THAT THE SHEATH SEPARATED DURING A DIFFICULT INFERIOR VENA CAVA (IVC) FILTER RETRIEVAL PROCEDURE. DURING THE ATTEMPTED RETRIEVAL THE IVC FILTER HOOK WAS FOUND TO BE EMBEDDED INTO THE CAVAL WALL SO THE FILTER WAS SNARED THROUGH THE STRUTS. THE HOOK WAS BENT UPON REMOVAL THROUGH THE SHEATH AND ONE SECONDARY STRUT FRACTURED. THE ENTIRE DEVICE WAS SUCCESSFULLY REMOVED TOGETHER AND ALL PIECES COUNTED AND ACCOUNTED FOR ON THE TABLE. THERE WAS NO REPORTED ADVERSE EVENTS OR INJURY TO THE PATIENT.
THE COMPLAINT DEVICE WAS RETURNED WITH NO RETURN AUTHORIZATION OR DETAILS. NUMEROUS ATTEMPTS HAVE BEEN MADE TO DETERMINE THE REASON FOR THE RETURN. PHOTOS OF THE RETURNED DEVICE INDICATED THE DEVICE WAS A PERFORMER SHEATH; WHICH DISPLAYED MATERIAL SEPARATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 704130 | INDY OTW VASCULAR RETRIEVER | MMX DEVICE, PERCUTANEOUS RETRIEVAL | MMX | COOK INC | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |