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

Model Number	PXSLIMSTR-B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
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 to treat pelvic varicose veins using a px slim delivery microcatheter (px slim), a ruby coil, non-penumbra catheter and a non-penumbra introducer sheath.During the procedure, a px slim was passed through a catheter to the pelvic varicose veins.Next, a ruby coil and polidocanol were placed successfully in the distal portion of the target location using the px slim.Afterwards, the physician advanced the catheter to the gonadal vein and subsequently, while advancing approximately five centimeters of the px slim through the rhv of the catheter, part of the px slim that was outside the patient broke.Therefore, the broken px slim was removed by pulling it out by hand.After the removal, while the physician examined the broken px slim, the physician further broke the px slim into two additional pieces.It was reported that the px slim was dry.The procedure was completed using a new px slim and the same introducer sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned px slim confirmed that the catheter was fractured.If the px slim is forcefully advanced against resistance at an extreme angle, damage such as a kink and subsequent fracture may occur.The root cause of resistance could not be determined.Further evaluation revealed additional fractures and kinks in the catheter shaft.This damage was incidental to the reported complaint.The fractures likely occurred while the physician was examining the px slim after removal as mentioned in the complaint.Penumbra catheters 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
• MDR Report Key: 12013692
• Report Number: 3005168196-2021-01346
• Device Sequence Number: 14309018
• 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): 08/30/2021
• 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: 08/06/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Date Report Sent to FDA: 01/01/2005