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

Catalog Number	PXSLIM045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the uterine artery using a px slim delivery microcatheter (px slim) and a non-penumbra catheter.During the procedure, the physician introduced the px slim into the target vessel and while attempting to torque the px slim to select the target vessel, the physician was unable to torque the px slim.Therefore, the px slim was removed.Upon removal, the physician noticed that the px slim was fractured at the proximal end.The procedure was completed using a non-penumbra microcatheter and the same catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned px slim confirmed a fracture on the proximal end.If the device is torqued against resistance, damage such as a fracture may occur.The root cause of resistance could not be determined.Further evaluation revealed ovalizations along the distal end of the catheter.This damage was incidental to the reported complaint and likely occurred due to the device being torqued during the procedure as mentioned in the reported complaint.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2023-00489 1.Section d.Box 4.Unique identifier.

• 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: 18059269
• Report Number: 3005168196-2023-00489
• Device Sequence Number: 7729298
• Product Code: DQY
• UDI-Device Identifier: 00814548016412
• UDI-Public: 00814548016412
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 06/14/2024
• 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: 04/12/2026
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F00006371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 11/10/2023; 01/14/2005
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/08/2023; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: 46 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005