MAUDE Adverse Event Report: COOK MEDICAL INCORPORATED MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET; DILATOR, VESSEL, FOR PERCUATNEOUS CATHETERIZATION

Model Number G48006

Device Problems Kinked (1339); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

Right common femoral artery entered with micropuncture needle on first attempt.Microwire first passed, went up into the renal bypass area, repositioned, then into the external iliac artery under fluoroscopy; however, could not pass beyond the proximal portion of the right external iliac artery, despite multiple attempts.With that being the case, i then inserted a microsheath and we did a hand injection, which showed no defect in the ap view.I did several small obliques, again could not see any issue.My plan was therefore to remove the microwire and try to pass a j-tip and in the process of removing that, it snagged on what appears to be plaque in the common femoral artery.Even with removal of the sheath this being the microsheath, could not retrieve the wire and therefore had to pull this back.With this in mind, i did let it to go but the tip did not appear to be intact and fluoroscopy showed that there was probably a cm and a half or so portion; all the wires still in what appeared be soft tissues.Tried to treat this percutaneously, but could not.Therefore, applied additional local into the area and did a small about 1-1/4 inch cutdown.Identified the wire into the soft tissues and removed it completely.Upon inspection, there was no knot in the wire, appeared to be kinked and it appeared to be snagged on a plaque on the anterior medial side of the common femoral artery at a puncture site.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Type of Device: DILATOR, VESSEL, FOR PERCUATNEOUS CATHETERIZATION
• Manufacturer (Section D): COOK MEDICAL INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 3912439
• MDR Text Key: 4515941
• Report Number: 3912439
• Device Sequence Number: 1
• Product Code: DRE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: G48006
• Device Catalogue Number: MPIS-501-10.0-SC-SST
• Device Lot Number: 4880895
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS
• Patient Age: 76 YR
• Patient Weight: 166