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

Catalog Number AB18W050120150

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Event Description

During an attempt to treat a lesion using powercross it was reported that the proximal marker is missing from the device.The balloon was inserted but not inflated.

Manufacturer Narrative

Device evaluation summary: the powercross dilatation catheter was received for evaluation.The powercross was received with the balloon chamber in a pre-inflation profile, (e.G.Tightly wrapped and winged).Sanguine residue was noted on the exterior of the balloon chamber.The returned state of the dilatation catheter was consistent with the initial reported event.The inner guide wire lumen within the balloon chamber was visually examined.No proximal marker band was noted in the proximal area of the balloon chamber.Visual examination confirmed the initial reported event.The distal marker band was present.The balloon chamber of the powercross was rinsed with water to remove the sanguine residue from the exterior of the balloon to aid visual inspection.The overall length of the dilatation catheter was examined.Several minor kinks were noted in the catheter.The kinks are located approximately 55.0cm, 105.7cm, 136.5cm and 139.5cm distal of the distal tip of the y-manifold strain relief.The kinks may have formed during the procedure, (e.G.During insertion or removal from the patient), or post-procedure given how the device was packaged for return.A 20cc water filled syringe was attached to the proximal hub luer lock on the y-manifold.The inner guide wire lumen was flushed: a clear steady stream of fluid was observed exiting the distal tip of the dilatation catheter.A 0.018¿ guide wire was able to be loaded through the distal tip of the dilatation catheter with ease.A 10cc water filled syringe was attached to the inflation lumen luer lock on the y-manifold.A vacuum could be pulled and maintained; indicated no leak in the inflatio n lumen.The balloon chamber was inflated: no leaks were noted.The inner guide wire lumen within the balloon chamber was visually examined: no proximal marker band was noted.A vacuum was pulled and the balloon chamber deflated with ease.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: POWERCROSS 018
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6386733
• MDR Text Key: 69326409
• Report Number: 2183870-2017-00116
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2018
• Device Catalogue Number: AB18W050120150
• Device Lot Number: A274173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR