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

Catalog Number	AB18W020100090
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2017
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 slightly tortuous and slightly calcified distal right anterior tibial artery exhibiting 50% stenosis.Embolic protection was not used.The device was removed from its packaging and inspected with no issues noted.A non-medtronic inflation device was used.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device and no excessive force was used.It was reported that the physician experienced inflation difficulties and that a contrast leak was noted at the proximal end of the balloon.It was reported that the physician was unable to deflate the balloon manually and that the balloon was slow to deflate by itself before the balloon was removed from the patient.The physician used another balloon to complete the procedure.
Additional Manufacturer Narrative
Evaluation summary: the powercross dilatation catheter was received for evaluation with the balloon chamber in a post-inflation profile, (not tightly wrapped or winged).The proximal balloon bond was examined: no abnormality was noted.Clear fluid was noted in the balloon chamber and sanguine residue was noted on the exterior of the balloon chamber.A 10cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed: sanguine colored fluid was observed exiting the distal tip of the catheter.The catheter was flushed until the fluid leaving the distal tip ran clear.An 0.018¿ guidewire was loaded through the distal tip of the dilatation catheter with ease and exited the proximal hub luer lock.A 20cc water filled syringe with manometer was attached to the inflation lumen luer lock on the y-manifold and the dilatation catheter was inflated to the nominal pressure of 8atm.The dilatation catheter was able to maintain this pressure for approximately one minute to allow for pictures to be taken.The dilatation catheter was then inflated to rated burst pressure of 14atm and was unable to maintain pressure.A leak in the y-manifold was noted.The leak was from the adhesive port on the y-manifold.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: 7012254
• Report Number: 2183870-2017-00486
• Device Sequence Number: 1496675
• Product Code: LIT
• UDI-Device Identifier: 00821684046104
• UDI-Public: 00821684046104
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/09/2018

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: 08/27/2018
• Device Catalogue Number: AB18W020100090
• Device Lot Number: A318527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 80