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

Catalog Number AB18W030200150

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2016

Event Type  malfunction  

Event Description

The physician intended to treat patient using a powercross balloon ((b)(4)).It was reported that the correct.018 x 3.0 x 200 mm was properly identified in the box but in the "catheter tip" was identified as.018 x 2.5 x 150 mm.Procedure was completed by using kissing technique "in arterial balloon popliteal and fibular with balloon 2.5 x 150 mm".No patient injury reported.

Manufacturer Narrative

Additional information - medical device correction/removal report number.

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: 5939585
• MDR Text Key: 54337861
• Report Number: 2183870-2016-00594
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K093286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2018
• Device Catalogue Number: AB18W030200150
• Device Lot Number: A213373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided; 09/13/2016
• Supplement Dates FDA Received: 09/23/2016; 09/25/2017
• Date Device Manufactured: 01/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2183870-03-30-2016-0
• Patient Sequence Number: 1
• Patient Age: 72 YR