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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 Problems Activation, Positioning or Separation Problem (2906); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2016
Event Type  malfunction  
Manufacturer Narrative
Results: the px slim delivery microcatheter (px slim) was kinked under the strain relief approximately 2.0 cm from the hub.The strain relief was accidentally fractured by a penumbra investigator during analysis.The px slim was fractured approximately 89.0 cm from the hub.Conclusions: evaluation of the returned devices revealed the pc400 pusher assembly and px slim were fractured.This damage likely occurred during the physician's attempt to retrieve the pc400.The segment of the pc400 pusher assembly distal to the fracture was not returned for evaluation.Further evaluation revealed the pc400 was damaged throughout its length, and the px slim was kinked.This damage may have occurred due to forceful handling during advancement of the pc400 through the px slim, or during packaging for return.Since the distal segment of the pusher assembly was not returned and both devices were returned severely damaged, the root cause of the complaint could not be determined.Px slim devices are 100% visually evaluated during in-process inspection, and pc400 devices are 100% visually and functionally 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: 3005168196-2016-00229.
 
Event Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 coils (pc400 coils) and a px slim delivery microcatheter (px slim).During the procedure, while the physician was advancing the twenty-fourth pc400 coil through the px slim, the pc400 coil became stuck inside the px slim.While the coil was being retracted, it started to unravel inside the px slim.The physician removed both the pc400 coil and the px slim from the patient.The procedure was completed at this time since the angiography showed that the target vessel was occluded.There was no report of an adverse effect to the patient.
 
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Brand Name
PX SLIM DELIVERY MICROCATHETER
Type of Device
DQY
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 Key5461810
MDR Text Key39089187
Report Number3005168196-2016-00230
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00814548016412
UDI-Public00814548016412
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K100826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other
Type of Report Initial
Report Date 01/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date08/31/2018
Device Catalogue NumberPXSLIM045-B
Device Lot NumberF65227
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/26/2016
Initial Date FDA Received02/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age39 YR
Patient Weight72
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