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

Model Number	PXSLIMSTR-B
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
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 using a px slim delivery microcatheter (px slim).During the procedure, the physician experienced resistance while advancing the px slim.Therefore, the px slim was removed.Upon removal, it was noted that the proximal end of the px slim was broken.The procedure was completed using a new px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned px slim confirmed fractures in the proximal shaft.If the device is forcefully manipulated against resistance during use, damage such as kinks and subsequent fractures may occur.The root cause of resistance during the procedure could not be determined.Further evaluation revealed that the device was kinked throughout its length and the strain relief was stretched.This damage was likely incidental to the 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.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12014224
• Report Number: 3005168196-2021-01347
• Device Sequence Number: 1376389
• 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): 08/25/2021
• 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: 07/20/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005