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

Catalog Number	AB18W030060150
Medical Device Problem Codes	Component Missing (2306); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image analysis: a set of four photographs of cine images was received for evaluation.Cine images one and three are identical.Cine images two and four are identical.Cine image one is of the powercross balloon inflated within the targeted vessel and the ancillary 0.018¿ nitrex guidewire.Only the powercross distal radiopaque marker band is visible.Image two is of the powercross not inflated on the 0.018¿ guidewire at the targeted vessel.Only the powercross distal radiopaque marker band is visible.Device analysis: the powercross dilatation catheter was received for evaluation.No ancillary devices from the procedure were received for evaluation.When removed from its protective transportation hoop it was noted that only the distal radiopaque marker was on the catheter.The balloon chamber was in a post inflated profile, (e.G.Not tightly wrapped or winged) and a clear fluid was noted within the balloon chamber.The proximal radiopaque marker band was found approximately 42.5cm proximal of the distal tip of the dilatation catheter.A 20cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed: a clear steady stream of fluid exited the distal tip of the dilatation catheter.A 0.018¿ guidewire was loaded through the distal tip of the dilatation catheter with ease.A 20cc water filled syringe was attached to the inflation lumen y-manifold luer lock and the balloon chamber was inflated.A vacuum was drawn, and the balloon chamber deflated.The balloon chamber was inflated to allow the examination of the balloon chamber¿s inner guidewire lumen.A witness mark was noted were the proximal radiopaque marker was swaged.Additional destructive testing was performed.The proximal radiopaque marker was located in the inflation lumen pathway.The dilatation catheter was cut proximal and distal of the radiopaque marker.The radiopaque marker slid off the inner guidewire lumen and the inner guidewire lumen was removed from the inflation pathway.The proximal radiopaque marker band did not exhibit witness marks of being swaged.There were no witness marks on the inner guidewire lumen where the marker band was located to indicate that an attempt to swage the marker band at that location.The balloon chamber was sliced opened and the inner guidewire lumen was removed from the dilatation catheter.No witness marks were noted on the inner guidewire lumen.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use balloon angioplasty treat a 100mm plaque lesion with 75% stenosis and no calcification in the mid left superficial femoral artery (sfa) using a powercross device and a nitrex 18 300cm guidewire.No tortuosity was reported.Pre-dilation was performed with 3x60 device (8atms and one inflation).After pre-dilation a 4x120 device was used (7 atm and 1 inflation).The powercross balloon usually has two radiopaque markers but it was noticed while positioning the balloon that the proximal marker on the balloon was not visible.The balloon was given opaque shape slightly to see the length of the balloon.The issue was noticed after the product was sent into the patient.The marker was not initially visible in the patient and it was reported that it did not fall off inside the patient.The procedure was completed normally.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7684711
• Report Number: 2183870-2018-00376
• Device Sequence Number: 732165
• Product Code: LIT
• UDI-Device Identifier: 00821684046623
• UDI-Public: 00821684046623
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2018
• Device Catalogue Number: AB18W030060150
• Device Lot Number: A266110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 80