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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. GUIDELINER V2 CATHETER PERCUTANEOUS CATHETER

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VASCULAR SOLUTIONS, INC. GUIDELINER V2 CATHETER PERCUTANEOUS CATHETER Back to Search Results
Model Number 5571
Device Problems Nonstandard Device (1420); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2012
Event Type  Malfunction  
Event Description

A guideliner v2 catheter was used during a clinical procedure. During the procedure, the pushwire separated from the polymer shaft of the catheter. The separated portion of the guideliner v2 was retrieved from the patient without impact.

 
Manufacturer Narrative

This event was reported to the manufacturer with no lot number. A review of the manufacturer's sales history indicated that the account's last shipment was for guideliner v2, lot 555038. Manufacturer's investigation confirmed that the shaft of the guideliner v2 had separated from the pushwire. The guideliner v2 manufacturing process includes a coating of (b)(4) which is applied to the shaft of a fully assembled catheter to serve as a lubricious agent. (b)(4). A root cause investigation revealed that the separation between the shaft and the pushwire likely resulted from (b)(4) contamination of lot 555038. Examination of the traveler for lot 555038 showed traces of (b)(4). The travelers for all other guideliner v2 lots were examined and no traces of (b)(4) were found. The remaining guideliner v2 lots in finished goods were tensile tested and did not exhibit the pushwire separation failure mode seen in this event. Further testing concluded that lot 555038 was the only lot that exhibited this failure mode. Manufacturer's investigation concluded the probable root cause of this event is due to (b)(4) contamination on the distal tip of the pushwire or the proximal liner of the shaft of lot 555038.

 
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Brand NameGUIDELINER V2 CATHETER
Type of DevicePERCUTANEOUS CATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS, INC.
6464 sycamore court
minneapolis MN 55369
Manufacturer (Section G)
VASCULAR SOLUTIONS, INC.
6464 sycamore court
minneapolis MN 55369
Manufacturer Contact
erin badali
6464 sycamore court
minneapolis, MN 55369
7636564300
MDR Report Key2430153
MDR Text Key2515772
Report Number2134812-2012-00005
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112082
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 01/27/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date11/30/2013
Device MODEL Number5571
Device LOT Number555038
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/09/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/08/2011
Is The Device Single Use? Yes
Type of Device Usage Initial
Removal/Correction Number2134812-01/17/2012-001R

Patient TREATMENT DATA
Date Received: 01/27/2012 Patient Sequence Number: 1
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