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

Catalog Number	CF7-7-100
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician used a closurefast catheter and 0.025 guidewire for radiofrequency ablation treatment of the greater saphenous vein (gsv).It was reported that the guidewire was used to maneuver the catheter up the vein.When the physician tried to remove the guidewire, it got stuck in the catheter.It was reported that there were several centimeters of guidewire extending out of the end of the catheter.Since physician was unable to remove the guidewire from the catheter, both the catheter and guidewire were both removed.During inspection of the guidewire, it was noticed that it looked like the outer coating broke and the end for the guidewire was connected by just the enter coil.The ultrasound tech and physician looked to see if any of the pieces of guidewire were left inside the vein.They could not determine if any of the guidewire remained in the vein using ultrasound and they also pulled their ¿c-arm¿ and took some fluoroscopic images that didn't show any retained metal.The vein was not ablated, but another vein was successfully ablated using a new catheter.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: the returned closurefast device was examined - the guidewire was seen unwinding and through the distal tip of the catheter.The guidewire was seen to be unwound at the end that is exiting the handle of the device.It was noted the guidewire is strung through the device, exiting both the distal tip and the handle.A kink was also observed on the device.The device was scathed on the shaft and the fep of coil removed and unwound to reveal underneath.The guidewire was fully removed from the catheter after scathing the shaft to find what was keeping it from being able to be removed.The guidewire was found to have a residue on it that likely was keeping the guidewire from being able to be removed from the catheter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLOSUREFAST CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6806613
• Report Number: 2183870-2017-00356
• Device Sequence Number: 16183564
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 163540053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Initial Date Received by Manufacturer: 07/22/2017
• Supplement Date Received by Manufacturer: 07/22/2017; 09/05/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 08/21/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1