MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM REPERFUSION CATHETER 041; NRY

Catalog Number PSC041

Device Problem Insufficient Information (3190)

Patient Problem Intimal Dissection (1333)

Event Date 04/13/2013

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the basilar artery (ba) using a penumbra system reperfusion catheter 041 and separator 041.Before the procedure, the patient was given 20,160,000 units of intravenous (iv) tissue plasminogen activator (t-pa).The catheter 041 was advanced to the ba along with a chikai 0.014 inch through an envoy 6f guiding catheter.Aspiration was done with a separator 041.After the procedure, 4,000 units of heparin was administered.The patient developed a dissection while the penumbra system moved into the p-com; therefore, the patient underwent percutaneous transluminal angioplasty (pta); however, the patient did not recover.Physician's comment: the cause of the event was difference in diameter between the psc041 and the chikai 0.014 inch.The event was related to the penumbra system.

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 3005168196-2014-00249.Device was disposed of by the hospital.

• Brand Name: PENUMBRA SYSTEM REPERFUSION CATHETER 041
• 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: 3765393
• MDR Text Key: 21966871
• Report Number: 3005168196-2014-00248
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072718
• 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: 03/27/2014

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: 05/31/2015
• Device Catalogue Number: PSC041
• Device Lot Number: F26304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2012
• 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: 70 YR
• Patient Weight: 59