MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM PUMP CANISTER; JCX

Catalog Number PAPS1

Device Problems Air Leak (1008); Suction Problem (2170); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.

Event Description

The patient was undergoing a thrombectomy procedure in the cerebral artery using a penumbra system pump canister (canister).During the procedure, the physician confirmed that all the devices were properly connected before switching on the penumbra aspiration pump 110v (pump).After advancing a catheter toward the thrombus and switching the pump on, the physician noticed the thrombus was not being aspirated through the aspiration tubing back into the canister.Upon observing the pressure gauge, the physician confirmed that the gauge would only go up to -10 in hg.After confirming that there was no issues with the connections to the pump, the physician noticed that there was air leakage from the canister.Therefore, all the devices were removed and the procedure was completed using another manufacturer's stent device.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM PUMP CANISTER
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5905173
• MDR Text Key: 53044643
• Report Number: 3005168196-2016-01237
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PAPS1
• Device Lot Number: B000258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1