MAUDE Adverse Event Report: COVIDIEN POWECROSS PTA; POWERCROSS PTA BALLOON

Model Number AB18W040120150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peripheral Vascular Disease (2002)

Event Date 03/25/2015

Event Type  Injury  

Event Description

The patient was enrolled in the (b)(6).The index procedure was performed on (b)(6), 2014.The target limb was the left distal sfa and popliteal segment 1.On (b)(6), 2014 the patient was treated for in-stent restenosis with a 6x80 stent placement.On (b)(6), 2015 the patient returned for target limb revascularization.A 4x120mm powercross balloon and a drug eluting balloon (deb) were used.The diameter of the stenosis was 100% (total occlusion), with a lesion length of 120mm.Then on (b)(6), 2015 the patient experienced a non-healing foot wound.The site became aware of this on june 8, 2015.The event required in-patient hospitalization for 11 nights.Medical/surgical intervention was required to prevent life-threatening illness or injury or permanent impairment to the body structure or function.The event is ongoing.

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.(b)(4).

Manufacturer Narrative

The physician name was received.

Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.  a capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.

• Brand Name: POWECROSS PTA
• Type of Device: POWERCROSS PTA BALLOON
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie riley ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 4947265
• MDR Text Key: 6033711
• Report Number: 2183870-2015-00262
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K093286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2016
• Device Model Number: AB18W040120150
• Device Catalogue Number: AB18W040120150
• Device Lot Number: A024647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 29