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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER DQY

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PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER DQY Back to Search Results
Catalog Number PXSLIM045-B
Device Problem Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2015
Event Type  Malfunction  
Manufacturer Narrative

Results: the px slim delivery microcatheter (px slim) was kinked approximately 0. 5 cm from the distal tip and ovalized approximately 1. 0 cm from the distal tip. Conclusions: evaluation of the returned devices revealed that the px slim was damaged in the distal shaft. This type of damage typically occurs due to improper handling during preparation or use. If the px slim is pinched or compressed during removal from the packaging, or advanced forcefully against resistance during insertion into the patient, damage such as this may occur. During testing, a 0. 025"mandrel was inserted into the hub of the px slim and advanced. Significant resistance was met when the mandrel reached the damage found on the distal end of the px slim. The damage found on the distal end of the px slim likely contributed to the resistance experienced by the physician while advancing the pc400 into the patient. Further evaluation revealed that the pusher assembly and embolization coil of the pc400 were damaged. This damage was likely due to forceful advancement of the pc400 against resistance. Pc400 devices are 100% functionally evaluated during in-process inspection. Px slim devices are 100% visually evaluated during in-process inspection. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. This report is associated with mfr report number: 3005168196-2015-01354.

 
Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using penumbra coil 400 coils (pc400 coils). During the procedure, the physician delivered another manufacturer's coil into the aneurysm as the first coil using a px slim delivery microcatheter (px slim). The physician then decided to deliver a pc400 coil as the second coil; however, resistance was met while advancing the pc400 coil through the px slim and they were both removed from the patient. The procedure continued using a new pc400 coil and a new px slim. There was no report of an adverse effect to the patient.

 
Manufacturer Narrative

(b)(4).

 
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Brand NamePX SLIM DELIVERY MICROCATHETER
Type of DeviceDQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer (Section G)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
kathleen kidd
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key5336720
MDR Text Key34763939
Report Number3005168196-2015-01355
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK100826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/02/2015
1 Device Was Involved in the Event
0 PatientS WERE 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 Date03/31/2018
Device Catalogue NumberPXSLIM045-B
Device LOT NumberF63367
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/28/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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