MAUDE Adverse Event Report: COVIDIEN NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	AB14W060150150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the nanocross elite 0.014 in over-the-wire pta balloon dilatation catheter was received for evaluation.No ancillary devices or cine images from the procedure were received.Not all components were returned; four radiopaque marker bands, approximately 150 mm of balloon chamber material, and distal tip were not returned.The nanocross elite was received in three segments: proximal segment includes the y-manifold, outer inflation sheath of the dilatation catheter, and inner guidewire lumen.The inflation lumen luer lock on the y-manifold contained biological sanguine residue.The distal end of proximal segment and the proximal end of the outer sheath showed signs of having been sheared off.The physician did outline that the external shaft of the dilatation catheter was intentionally cut.The interior of the inflation lumen contained biological sanguine residue.The distal separation face of the outer sheath contained the proximal balloon bond.The blue inner guidewire lumen exhibited tensile and torsional stretching.The returned nanocross elite dilatation catheter exhibited a radial ruptured proximal balloon cone.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a nanocross elite with a non-mdt 7 fr sheath and non-mdt 0.14 300 mm guidewire for treatment of a severely calcified cto (chronic total occlusion-100%) 175 mm lesion in the patients left proximal common femoral artery (diameter 6 mm)and external iliac artery (diameter 7-8 mm).It was reported that upon completion of the first inflation, to 12 atm, of the balloon in the common femoral artery, the balloon burst.The physician noted the burst and gave time for the device to deflate on its own.Upon attempting to withdraw the device, resistance was noted, the balloon would not withdraw.It was reported that the physician pulled back multiple times, unsuccessfully, to withdraw the balloon.The physician then cut and removed the external jibbed portion of the balloon shaft with only the internal (thin blue coloured portion) exposed and attached to the balloon still inside the patient, through the sheath over the wire.The physician removed the 7 french sheath and continued to attempt removal of the balloon over the wire.The balloon eventually became detached from shaft with the shaft being removed over the wire and the elite balloon bunched up in the external iliac.The physician then proceeded to tack the balloon to the wall of the vessel via a 6x 57 balloon expandable stent.Once the balloon was securely tacked, the physician then proceeded to continue the intervention using another pta balloon.No patient injury was reported.

• Brand Name: NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7399555
• Report Number: 2183870-2018-00207
• Device Sequence Number: 16498030
• Product Code: LIT
• UDI-Device Identifier: 00821684067147
• UDI-Public: 00821684067147
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2020
• Device Catalogue Number: AB14W060150150
• Device Lot Number: A565841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 70