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U.S. Department of Health and Human Services

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

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PENUMBRA, INC. LANTERN DELIVERY MICROCATHETER DQY Back to Search Results
Model Number PXSLIMLAN115T45
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
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: 3005168196-2021-01446. 3005168196-2021-01447. 3005168196-2021-01448.
 
Event Description
The patient was undergoing a coil embolization procedure in the subclavian artery using ruby coils, lantern delivery microcatheters (lantern), a non-penumbra sheath, and a 4f glide catheter. During the procedure, the physician advanced two ruby coils into the target vessel using the lantern; however, both coils were determined to be oversized. Therefore, both ruby coils were removed. The physician then attempted to advance a new ruby coil through the lantern; however, the ruby coil would not advance. Upon further inspection, the physician noticed a kink towards the hub of the lantern. Therefore, the ruby coil was removed and saved for later use. The physician then removed the damaged lantern and inserted a new lantern into the patient. Afterwards, the physician implanted the previously removed ruby coil in the target vessel. While advancing a new ruby coil through the lantern, the physician experienced resistance but was able to implant the ruby coil in the target vessel. Subsequently, when the scrub technologist was retracting the lantern without a guidewire, both ruby coils were pulled back into the brachial artery. Therefore, the physician used a snare device to remove both ruby coils. The physician decided to end the procedure at this point and planned to bring the patient back in on a later date. There was no report of an adverse effect to the patient.
 
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Brand NameLANTERN DELIVERY MICROCATHETER
Type of DeviceDQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key12097702
MDR Text Key259460525
Report Number3005168196-2021-01449
Device Sequence Number1
Product Code DQY
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K152840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,06/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPXSLIMLAN115T45
Device Catalogue NumberPXSLIMLAN115T45
Device Lot NumberF102496
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
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2020
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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