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

Model Number	AB14W030210150
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician used the nanocross 014 to treat a heavily calcified long lesion with 95% stenosis in the superficial femoral artery as per ifu.It was reported that difficulty was experienced removing the balloon following balloon inflation and resistance was encountered removing the catheter from the patient.The catheter was pulled back into the sheath, it was observed that the balloon had detached within the sheath.The sheath was removed flushed and inserted back into the patient with no issues noted.The procedure was completed without injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NANOCROSS 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: 6386730
• Report Number: 2183870-2017-00115
• Device Sequence Number: 16327614
• Product Code: LIT
• UDI-Device Identifier: 00821684066522
• UDI-Public: 00821684066522
• 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,Followup
• Report Date (Section B): 02/07/2017

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 Expiration Date: 01/06/2020
• Device Model Number: AB14W030210150
• Device Lot Number: A396829
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: 02/07/2017
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 64