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

Model Number AB18W050060150

Device Problems Break (1069); Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

During inflation of the balloon calcium punctured a hole and the balloon deflated.Upon removing the balloon from the vessel, the balloon tore.The balloon came apart and was difficult to extract out of the sheath.

Manufacturer Narrative

A review of manufacture records for this device did not reveal any discrepancies relevant to the reported event.This complaint was submitted to the fda from the site via medwatch form.Reference uf/importer # (b)(4).

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.(b)(4).

• Brand Name: POWERCROSS
• Type of Device: TRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER
• 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: 4437499
• MDR Text Key: 5381721
• Report Number: 2183870-2015-00016
• 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: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2016
• Device Model Number: AB18W050060150
• Device Catalogue Number: AB18W050060150
• Device Lot Number: 9932217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR