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U.S. Department of Health and Human Services

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

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THE SPECTRANETICS CORPORATION SPECTRANETICS QUICK-CROSS SUPPORT CATHETER Back to Search Results
Model Number 518-065
Device Problems Mechanical Problem (1384); Material Puncture/Hole (1504); Material Perforation (2205); Device Damaged by Another Device (2915)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2018
Event Type  Malfunction  
Manufacturer Narrative

Patient gender and weight not available from the site. Visual examination of catheter confirmed a hole was present 5mm from the distal tip. Likely cause is the user encountered resistance in the anatomy, the catheter deflected, and the guide-wire continued straight, puncturing the catheter. A couple kinks were found along the catheter as well.

 
Event Description

During a peripheral vascular surgery utilizing femoral access, the surgeon stated when using the quick-cross support catheter 518-065, they could not go as low in the leg as wished, past the proximal anterior tibial artery. Also, when taking out the quick-cross they noticed a hole in the catheter above the tip. No device remnants were detected to be left in the patient. The case was successfully completed with a balloon and guide-wire. No impact on patient outcome due to this event. This is being reported due to the potential for serious injury with recurrence.

 
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Brand NameSPECTRANETICS QUICK-CROSS SUPPORT CATHETER
Type of DeviceQUICK-CROSS
Manufacturer (Section D)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
Manufacturer Contact
catherine eaton
9965 federal drive
colorado springs, CO 80921
719447-246
MDR Report Key7920057
MDR Text Key122163672
Report Number1721279-2018-00129
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK072750
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,09/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/22/2019
Device MODEL Number518-065
Device Catalogue Number518-065
Device LOT NumberFQV17F21A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received09/04/2018
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 09/28/2018 Patient Sequence Number: 1
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