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

MAUDE Adverse Event Report: AV-TEMECULA-CT PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

  • 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
 

AV-TEMECULA-CT PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM Back to Search Results
Catalog Number 12673-03
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/25/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Estimated date of occurrence, exact date was not known. The other proglide device that was referenced is being filed under a separate medwatch mfr number. It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed. A review of the lot history record revealed no non-conformances that would have contributed to the reported event. Based on the information reviewed, there is no indication of a product deficiency. Nine unused, sterile representative samples with the same part number were returned for evaluation. Functional testing was performed on the nine returned devices and the devices passed with acceptable results. No manufacturing issues or abnormal observations were detected. A cause for the reported experience could not be determined based on the investigation findings from the tested samples.
 
Manufacturer Narrative
(b)(4). Correction - lot number changed from 30124j1 to 30226k1. Correction - expiration date changed from 01/31/2015 to 02/28/2015. Correction - device returned on (b)(4)2013. Correction - manufacturing date changed from 01/2013 to 02/2013. Evaluation summary: the device was returned for evaluation. The reported event was confirmed. Based on the visual inspection and functional analysis of the returned device, there is no indication of a product deficiency. A review of the lot history record revealed no non-conformances that would have contributed to the reported event. Results of the query of similar incidents in the complaint handling database from this lot did not indicate a manufacturing issue. Based on the information reviewed, there is no indication of a product deficiency.
 
Event Description
It was reported that an arteriotomy closure of a common femoral artery was attempted using a proglide device with a 6f sheath, after an unspecified procedure. Reportedly, no suture was present when the plunger was pulled, a cuff miss occurred. A second proglide was used with the same results. A non-abbott device was used to achieve hemostasis. There was no reported adverse patient sequela or clinically significant delay in the procedure or therapy. The physician is reportedly trained in the use of the proglide device. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
Type of DeviceSUTURE MEDIATED CLOSURE
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer (Section G)
REDWOOD CITY, CA USA REG# 2953144
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key3070312
MDR Text Key10715279
Report Number2024168-2013-02467
Device Sequence Number1
Product Code MGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/28/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2015
Device Catalogue Number12673-03
Device Lot Number30226K1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/11/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
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: 04/22/2013 Patient Sequence Number: 1
Treatment
SHEATH: 6F
-
-