MAUDE Adverse Event Report: PENUMBRA, INC. SLIM PENUMBRA CATHETER 025 (PX400 MICROCATHETER); DQY

Model Number	PXSLIM045-B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure in the deep and shallow femoral artery using a px slim delivery microcatheter (px slim) and a non-penumbra guiding sheath.During the procedure, while advancing a px slim from the contralateral side and then turning from one iliac branch to another, it was noticed that the mid-shaft of the px slim was broken.Therefore, the px slim was removed.On the back table, while examining the broken px slim, the px slim broke again in another area.Therefore, the px slim was no longer used for the remainder of the procedure.The procedure was completed using a new px slim and the same guiding sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned px slim confirmed, a mid-shaft fracture.Probable cause of this damage may be, due to forceful handling, during manipulation of the device within the patient¿s vessel.If the device is mishandled at extreme angles during use, damage such as a kink and subsequent fracture may occur.Further evaluation confirmed, an additional fracture on the mid-shaft and revealed, a kink and ovalizations on the distal shaft.The additional fracture was reported to have occurred during examination.The kink and ovalizations were likely incidental to the reported complaint.And the root cause could not be determined.Penumbra catheters are 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.H3 other text: placeholder.

• Brand Name: SLIM PENUMBRA CATHETER 025 (PX400 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: 12565726
• Report Number: 3005168196-2021-02179
• Device Sequence Number: 16497756
• Product Code: DQY
• UDI-Device Identifier: 00814548016412
• UDI-Public: 00814548016412
• Combination Product (Y/N): Y
• Initial Reporter Country: DR
• 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,Followup
• Report Date (Section B): 11/09/2021
• 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: 10/08/2021
• 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: 09/08/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 11/09/2021
• 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: 39 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005