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

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

  • 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
 

PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER; DQY Back to Search Results
Catalog Number PXSLIMSTR
Device Problem Compatibility Problem (2960)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2019
Event Type  malfunction  
Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 numbers: 3005168196-2019-01513, 3005168196-2019-01514, 3005168196-2019-01515, 3005168196-2019-01516, 3005168196-2019-01517, 3005168196-2019-01518, 3005168196-2019-01519, 3005168196-2019-01520.
 
Event Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using a px slim delivery microcatheter (px slim), a neuron max 6f 088 long sheath (neuron max), a benchmark 6f 071 delivery catheter (benchmark), and penumbra smart coils (smart coils).It should be noted that there was a tortuous tonsillar loop in the common carotid artery (cca).During the procedure, the physician advanced the neuron max into the patient¿s anatomy but felt that it would not provide enough support to guide the px slim over the tonsillar loop.Therefore, the neuron max was removed and was no longer used in the procedure.The physician then decided to use a benchmark as the guide.However, while advancing the benchmark halfway through the tonsillar loop, it was reported that the benchmark felt stiff.The physician decided not to advance the benchmark any further into the patient¿s anatomy and it was therefore removed from the procedure.A non-penumbra sheath was then advanced, followed by the same px slim; however, the px slim was not compatible with the technique the physician preferred to use and was therefore removed from the procedure.There was no other issue noted with the px slim.A non-penumbra microcatheter was then successfully advanced through the sheath and into the target location and several smart coils and other coils were implanted into the aneurysm.It was also reported that the physician experienced a "coarse" and "grainy" feeling while advancing a 5x15 smart coil through the microcatheter.Additionally, the 5x15 smart coil was only able to advance approximately 60% of the way out of the microcatheter.The 5x15 smart coil was therefore retracted and removed from the procedure.While attempting to advance another smart coil, the physician noted that it was only able to advance approximately 1 cm from its initial position within its introducer sheath.This smart coil was subsequently removed and was not used in the procedure.The same issue also occurred with four additional smart coils; these smart coils were also removed and were not used in the procedure.The procedure was completed successfully using forty coils.There was no report of an adverse effect to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PX SLIM DELIVERY MICROCATHETER
Type of Device
DQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key8858101
MDR Text Key153355463
Report Number3005168196-2019-01512
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00814548016436
UDI-Public00814548016436
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K100826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 01/01/2005,05/17/2019
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 Health Professional
Device Expiration Date01/06/2020
Device Catalogue NumberPXSLIMSTR
Device Lot NumberF73551
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 05/17/2019
Initial Date FDA Received08/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-