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

Model Number	PXSLIMSTR-B
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
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 coil embolization procedure in the hemorrhoidal artery using a px slim delivery microcatheter (px slim), a non-penumbra diagnostic catheter and a micro-guidewire.During the procedure, the physician experienced resistance while advancing the px slim over a guidewire through the diagnostic catheter to the patient¿s target vessel due to the patient¿s tortuous anatomy.Upon injecting contrast, the physician was unable to see the patient¿s vessel due to the contrast passing through the diagnostic catheter and not through the px slim.Subsequently, it was noticed that one third of the proximal end near the hub of the px slim was fractured.Therefore, the physician removed the px slim along with the diagnostic catheter.It was reported that while the physician removed the px slim, the physician furthered fractured the px slim.The procedure was completed using a non-penumbra microcatheter and the same diagnostic catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned px slim confirmed a proximal fracture.If the device is forcefully manipulated at extreme angles during use, the device may become kinked and subsequently, if the kinked device is further manipulated, it may fracture.Further evaluation of the device revealed an additional fracture and kinks throughout the catheter length.This damage was likely incidental to the complaint and may have occurred during removal from the patient and packaging for return.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.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11446145
• Report Number: 3005168196-2021-00460
• Device Sequence Number: 17018424
• Product Code: DQY
• UDI-Device Identifier: 00814548016443
• UDI-Public: 00814548016443
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021
• 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: 09/29/2023
• Device Model Number: PXSLIMSTR-B
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F100620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005