• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN POWERCROSS TRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN POWERCROSS TRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER Back to Search Results
Model Number AB18W050100150
Device Problems Balloon; Deflation Problem; Fitting Problem; Activation, Positioning or Separation Problem
Event Date 10/14/2014
Event Type  Injury  
Event Description

Upon inflation of the powercross, the mid-proximal portion of the balloon would not unwrap. It was inflated to nominal for 4 mins. The physician then pulled negative to deflate, but it would not deflate. The physician tried again, still nothing. The physician then tried a syringe and applied pressure behind knee (balloon was in the popliteal). Finally the physician tried pulling the balloon into the sheath, but it would not completely fit. The physician had to pull the sheath and balloon out as a unit.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

This supplemental mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien plymouth 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.

 
Event Description

Evaluation summary: the powercross catheter was received for evaluation loaded in the cook 6fr guide sheath referenced in the complaint description. The balloon chamber was partially drawn into the sheath lumen. The catheter shaft exhibited stretching, necking, kinking and longitudinal buckling at the proximal end of the guide sheath. Damage of this nature would render any attempt to quantify inflation/ deflation times for t=0 (original state) impossible. Damage of this nature is consistent with trying to pull a partially deflated balloon through a guide sheath. The balloon proximal balloon bond exhibited longitudinal creases that could have compromised luminal clearance and adversely affect inflation/ deflation times.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOWERCROSS
Type of DeviceTRANSLUMINAL PERIPHERAL ANGIOPLASTY CATHETER
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth
Manufacturer Contact
stephanie riley
4600 nathan lane north
plymouth , MN 55442
7633987000
MDR Report Key4247725
Report Number2183870-2014-00286
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/26/2016
Device MODEL NumberAB18W050100150
Device Catalogue NumberAB18W050100150
Device LOT Number9918208
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/23/2014
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/28/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/13/2014 Patient Sequence Number: 1
-
-