MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM REPERFUSION CATHETER 054; NRY

Catalog Number PSC054

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 08/06/2012

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) (m1) using a penumbra system reperfusion catheter 054 and separator 054.Before the procedure, intravenous tissue plasminogen (iv t-pa) was not injected.During the procedure, the physician advanced a reperfusion catheter 054 to the m1 along with a chikai 0.014 inch through an optimo 9fr.Aspiration was conducted with a separator 054.The patient was then given 5,000 units of heparin by injected.The patient experienced a dissection while the penumbra system was being inserted.Stenting was done in the dissected vessel.As of (b)(6) 2012 the patient recovered.Physician's comment: the relation between the event and the penumbra system was not denial, since dissection occurred while the psc054 was being inserted.

Manufacturer Narrative

Conclusion: dissection is a known and anticipated complication with these types of procedures and is noted in the device labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This mdr is associated with mdr 3005168196-2014-00291.Device was disposed of by hospital.

• Brand Name: PENUMBRA SYSTEM REPERFUSION CATHETER 054
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 3808943
• MDR Text Key: 4525820
• Report Number: 3005168196-2014-00286
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: PSC054
• Device Lot Number: F24925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2014
• Initial Date FDA Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 40