MAUDE Adverse Event Report: COVIDIEN POWERCROSS 018; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	AB18W050150150
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a powercross pta balloon to treat a 140mm moderately calcified plaque lesion in the distal right sfa (50% stenosis).The artery had a diameter of 5mm and was moderately tortuous.The device was prepped as per the ifu with no issues identified.The procedure used a 6 fr non-medtronic sheath and a 0.018" non-medtronic guidewire.No resistance was encountered advancing the device, the device did not pass through a previously deployed stent and no excessive force was used.It was reported that during the first inflation at 12 atm pressure, the contrast from the balloon was seen seeping out of the balloon.The balloon was deflated and removed.No tear on balloon was observed, balloon remained intact.Another powercross pta balloon was used to complete the procedure without incident.No patient injury was reported.

• Brand Name: POWERCROSS 018
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7236534
• Report Number: 2183870-2018-00057
• Device Sequence Number: 11007925
• Product Code: LIT
• UDI-Device Identifier: 00821684046821
• UDI-Public: 00821684046821
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K093286
• 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
• Report Date (Section B): 02/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: AB18W050150150
• Device Lot Number: A320568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1