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

Catalog Number	AB18W060060150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician attempted to treat patient at the proximal superficial femoral artery using a powercross balloon.Target lesion type was reported to be "soft tissue" with no tortuosity, no calcification and 100% stenosis (cto).It is reported that balloon burst during inflation to 6 atm with an everest inflation device.It was reported that none of the components detached or embolized.The procedure was reported to have been completed using another balloon.No patient injury was reported.
Additional Manufacturer Narrative
Additional information received confirmed that burst occurred at the shaft of the device.It also stated that no component embolization occurred.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: the powercross dilatation catheter was received with the balloon chamber in a post-inflated profile.Three kinks in the dilatation catheter were noted, the kinks most likely happened post-procedure given how the device was packaged for return and how the kinks align with the coiled device.The kinks are located approximately at 38.5cm, 86.5cm, and 134.5cm from the distal tip of the strain relief of the y-manifold.A 10cc water filled syringe was attached to the proximal hub luer lock of the y-manifold and the guidewire lumen was flushed: a clear steady stream of fluid was observed exiting the distal tip of the dilatation catheter.A 0.018¿ compatible guidewire was loaded through the distal tip of the dilatation catheter and would only advance to the first kink it encountered.A 10cc water filled syringe was attached to the inflation luer lock on the y-manifold in order to inflate the balloon chamber.Fluid was noted leaking from the distal tip of the y-manifold strain relief.A kink in the catheter was noted at the distal tip of the y-manifold strain relief.The printed strain relief of the y-manifold was removed to allow further examination of the catheter and y-manifold.A second attempt to inflate the balloon was made and fluid was observed leaking from the y-manifold to catheter bond.With the aid of a microscope the outer catheter shaft to manifold bond was examined.No excessive amounts of bubbles, or large bubbles were observed.The adhesive appears to be clear.The proximal end of the outer sheath is at the hard stop of the manifold.The manifold was placed in a shallow container of water and air was passed through the inflation lumen to aid in the locating of the leak pathway.The leak appears to run along the base of the outer catheter shaft.Red dye was used to further identify the leak pathway.Per the initial reported event the burst occurred when the balloon was inflated to 6 atm.Per label claim nominal pressure of the powercross dilatation catheter is 8 atm and has a rated burst pressure of 14 atm.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: 6442428
• Report Number: 2183870-2017-00148
• Device Sequence Number: 16288395
• Product Code: LIT
• UDI-Device Identifier: 00821684046869
• UDI-Public: 00821684046869
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K093286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/08/2017

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: 07/03/2017
• Device Catalogue Number: AB18W060060150
• Device Lot Number: A115964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided; 03/21/2017; 11/09/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 04/18/2017; 09/06/2017; 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1