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

Model Number	PXSLIM045-B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
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.This report is associated with mfr report number: 3005168196-2021-02144.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) using a px slim delivery microcatheter (px slim), pac400 coil, pod400 coil and penumbra smart coils (smart coil).During the procedure, the physician placed a few pod400 and pac400 into the target location.While attempting to advance the px slim to cross a lesion second time, the proximal end of the px slim kinked.Consequently, the pac400 and pod400 would not deploy.Therefore, the px slim, pac400 and pod400 were removed.It was reported that the pod400 and pac400 did not have any issue.Next, the physician used a non-penumbra microcatheter and placed several smart coils in the target location; however, the subsequent smart coil would not advance past the friction lock within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using three non-penumbra coils, two more smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned px slim revealed a fracture on the mid-shaft.This damage may be the reported kink on the proximal shaft, confirming the reported complaint.If the device is manipulated at extreme angles during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed ovalizations on the distal shaft.This damage was likely incidental to the reported complaint and the root cause could not be determined.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted into the introducer sheath friction lock.This is likely the probable cause of the reported complaint.If the mid-joint is retracted into the friction lock, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the pusher assembly kinks near the mid-joint.The smart coil was unable to be advanced from its returned position within the introducer sheath during the functional test.Penumbra catheters and coils 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.This report is associated with mfr report number: 1.3005168196-2021-02144.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12544741
• Report Number: 3005168196-2021-02143
• Device Sequence Number: 19859177
• Product Code: DQY
• UDI-Device Identifier: 00814548016412
• UDI-Public: 00814548016412
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021
• 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: 09/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005