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

Catalog Number PMX110

Device Problems Misconnection (1399); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2019

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 aspiration pump max 110 (pump max).During the procedure, a penumbra system 3max reperfusion catheter (3maxc) and aspiration tubing (tubing) was accidentally connected directly to the pump max rather than the canister.Consequently, blood was aspirated into the pump max.The physician had a successful recanalization using the same pump max, 3maxc and tubing after a single pass and completed the procedure.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note a correction was made to section h3 box 3.Device returned to manufacturer?: corrected from "no" to yes.Results: dried blood was found on the returned pump max housing.Conclusions: evaluation of the returned pump max confirmed blood was aspirated inside the vacuum pump.The reported complaint indicated that the aspiration tubing was directly connected to the pump inlet instead of the canister and blood was aspirated into the pump.If the fluid enters the vacuum pump assembly, the pump may not function properly.Penumbra pumps are visually inspected and functionally tested during incoming quality inspection.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8671256
• MDR Text Key: 147099395
• Report Number: 3005168196-2019-01093
• Device Sequence Number: 1
• Product Code: JCX
• 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: 01/01/2005,05/07/2019

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: F06928-17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• 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: 05/07/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR