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

Model Number	PXSLIM045-B
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left femoral artery using a px slim delivery microcatheter (px slim), penumbra coil 400 (pc400s), a penumbra coil 400 detachment handle (handle), and a 5f guide catheter.During the procedure, the physician advanced the 5f guide catheter close to the fistula, then advanced a px slim through the guide catheter and into the target location without any issue.Subsequently, the physician advanced a pc400 with resistance into the target location using the px slim and detached the pc400 using the handle.Next, while advancing another pc400 into the target location using the px slim, the physician experienced resistance and, therefore, decided to remove the pc400 and saved for later use.The physician then attempted to advance the px slim to loosen the resistance; however, when the physician injected contrast through the px slim, the midshaft of the px slim was noticed to be damaged.Therefore, the px slim was removed and confirmed to be kinked.The procedure was completed using a new px slim, the same pc400, and handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned px slim revealed that the catheter was fractured.This fracture is likely the reported kinked location.If the px slim is manipulated against resistance, damage such as a kink may occur.Further manipulation of a kinked device may worsen to a fracture.The root cause of resistance could not be determined.Penumbra products are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: 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 Key: 12926034
• Report Number: 3005168196-2021-02734
• Device Sequence Number: 5647755
• Product Code: DQY
• UDI-Device Identifier: 00814548016412
• UDI-Public: 00814548016412
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2021
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: PXSLIM045-B
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F104034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005