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

MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS QUICK-CROSS SUPPORT 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
 

SPECTRANETICS CORPORATION SPECTRANETICS QUICK-CROSS SUPPORT CATHETER Back to Search Results
Model Number 518-036
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/26/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

A pt with conglomerative retroperitoneal mass was undergoing an inferior vena cava recanalization with stent placement, the distal end of the quick cross catheter broke off. The broken piece of the catheter was successfully retrieved.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSPECTRANETICS QUICK-CROSS SUPPORT CATHETER
Type of DeviceQUICK-CROSS
Manufacturer (Section D)
SPECTRANETICS CORPORATION
9965 federal dr.
colorado springs CO 80921
Manufacturer (Section G)
SPECTRANETICS
Manufacturer Contact
sondra chandler
9965 federal dr
colorado springs, CO 80921
719447-253
MDR Report Key5337144
MDR Text Key35253535
Report Number1721279-2015-00196
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK033678
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date11/24/2016
Device MODEL Number518-036
Device Catalogue Number518-036
Device LOT NumberFQP14L24A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/24/2014
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: 12/30/2015 Patient Sequence Number: 1
-
-