MAUDE Adverse Event Report: COVIDIEN CLOSUREFAST CATHETER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number CF7-7-100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician intended to use a closurefast catheter to treat the great saphenous vein.The ifu was followed during the procedure.The device was used successfully on two segments.While treating the last section of the second segment, the physician reported hearing a pop and sizzle noise.The catheter and sheath were removed together as they were unable to be separated.It was reported that the sheath had melted onto the catheter and a hole was reported in the partially melted sheath.All parts of the devices have been accounted for.The patient did not report pain, no injury was reported and no additional treatment was required.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The generator did not display any error message.Customer reported that follow up took place 2 days and 6 days post procedure to rule out a dvt.Customer reported no skin damage was noted and that the patient was doing well.The patient had no pain and no further treatment was needed.Evluation summary: the closurefast catheter was returned for evaluation.Ancillary device is-7f07 introducer sheath was returned with the closurefast catheter.The closurefast catheter heating element/coil was observed inserted within the introducer sheath.The closurefast and introducer sheath were examined: the coil /heating element of the closurefast catheter was stuck inside the sheath of the introducer and was unable to be removed.Approximately 12mm of the coil and catheter section was stuck within the introducer sheath.A slight bend was observed in the coil.A kink was observed on the catheter shaft.Visual inspection of the introducer sheath revealed the sheath was melted onto the coil.A hole was observed in the partially melted sheath.Blood residue was observed within the clear tubing of the introducer.Due to the melted sheath, the closurefast catheter was unable to be removed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLOSUREFAST CATHETER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• MDR Report Key: 7380735
• MDR Text Key: 104036461
• Report Number: 2953189-2018-00005
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 171490178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 06/20/2018; 08/08/2018
• Supplement Dates FDA Received: 07/18/2018; 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR