MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110; NRY

Catalog Number PMX110

Device Problems Device Emits Odor (1425); Suction Problem (2170); Excessive Heating (4030)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2019

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 using a penumbra system aspiration pump max 110 (pump max).During the procedure, the physician noticed that the pump max had gotten very warm and smelled hot.It was reported that the pump max also had reduced aspiration power; therefore, it was removed.The procedure was completed using manual aspiration with a syringe.The patient had deficits post procedure caused by the index stroke that the patient was originally being treated for.

Manufacturer Narrative

Results: the pump max was able to power on and produce a vacuum pressure of approximately -29.0 inhg.The pump max was ran continuously for approximately 30 minutes and the vacuum pressure remained the same and no unusual smell was noticed.Conclusions: evaluation of the returned pump max revealed an undamaged device.During functional testing, the pump max was powered on and was able to produce a vacuum pressure within specification.The reported smell and reduce aspiration power could not be confirmed.Penumbra pumps are visually inspected and functionally tested during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8462829
• MDR Text Key: 140268768
• Report Number: 3005168196-2019-00590
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• 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: 01/01/2005,02/28/2019

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 Catalogue Number: PMX110
• Device Lot Number: F25844-42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• 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: 02/28/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 04/02/2019
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR