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 04/18/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, the patient suffered cardiogenic embolism in the right mca (m1).(presymptomatic mrs score: 2, pretreatment nihss score: 15) iv t-pa was not injected.(aspects score: 8, tici score: 0).A psc054 was advanced to the anterior m1 with a psc032 coaxially along a synchro 2 guidewire 0.014 inch through an optimo guide catheter 9fr.Angiography, which was conducted through the psc032 placed in the m2, slowly showed a dissection in the distal m2.Aspiration was conducted with a pss054 and 3,000 units of heparin were injected.(tici score: 2b, aspects score: 5, nihss score: 15).The patient developed asymptomatic sah.The physician closely monitored the patient's condition but withholding treatment.As of (b)(6) 2013 the patient had recovered.Physician's comment: occlusion occurred in the proximal m1.I placed the psc054 in the distal mca and the psc032 in the m2.Tandem lesions were observed in the delayed angiograph.I conducted aspiration with the psc054 after advancing it to the m2.Since the events happened after the procedure, they are not 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 3005168196-2014-00295.Hospital disposed of device.

• 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: 3808893
• MDR Text Key: 4389059
• Report Number: 3005168196-2014-00294
• 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: 02/28/2015
• Device Catalogue Number: PSC054
• Device Lot Number: F24541
• 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: 02/02/2012
• 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): Other
• Patient Age: 68 YR
• Patient Weight: 51