MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM MAX ASPIRATION TUBING; NRY

Catalog Number 3MAXCKIT

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system max aspiration tubing (tubing) packaged with the penumbra system 3max hi-flow kit.During the procedure, the physician noticed that the lumen of the penumbra system 3max reperfusion catheter (3maxc) would not open and there was no aspiration generated after turning on the tubing flow switch.After flipping the flow switch back and forth, aspiration was achieved.It was reported that the tubing would not work properly every time.The procedure was completed using the same 3maxc, tubing, and velocity.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: there was no visible damage to the tubing.Conclusions: evaluation of the returned tubing confirmed the reported complaint.During functional testing, the flow switch was cycled back and forth and no issue was observed with the flow switch and plunger.However, while under aspiration, the flow switch was switched from ¿off¿ to ¿on¿ and the plunger became stuck and would not allow aspiration.The flow switch was then cycled back to ¿off¿ then ¿on¿ and aspiration was observed.On subsequent testing, the plunger would not get stuck.The root cause of the plunger becoming stuck could not be determined.The 3maxc and velocity were not returned for evaluation.Penumbra tubing 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.Section h.Box 6.Conclusions code 1: 4316 ¿ the investigation findings do not lead to a clear conclusion about the cause of the plunger becoming stuck.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM MAX ASPIRATION TUBING
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8599011
• MDR Text Key: 144688719
• Report Number: 3005168196-2019-00944
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019949
• UDI-Public: 00814548019949
• Combination Product (y/n): Y
• PMA/PMN Number: K151623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Catalogue Number: 3MAXCKIT
• Device Lot Number: F81909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/13/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 95 YR