MAUDE Adverse Event Report: PENUMBRA, INC. VELOCITY DELIVERY MICROCATHETER; DQY

Catalog Number VEL160STR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Anemia (1706)

Event Date 11/12/2014

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the right middle cerebral artery using a penumbra system 5max ace reperfusion catheter and a velocity delivery microcatheter.During the procedure the patient experienced mild anemia with an uncertain relationship to the 5max ace catheter and velocity microcatheter, an uncertain relationship to the angiographic procedure, and unrelated to the index stroke.No further action was taken and the event was unresolved.The patient also experienced a distal embolization with a possible relationship to the 5max ace catheter and velocity microcatheter.The distal embolization was resolved later the same day.

Manufacturer Narrative

Conclusion: distal embolization is a known and anticipated complication with these types of procedures and are noted in the device labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.This mdr is associated with mdr 3005168196-2015-00423.The hospital discarded the device.

Manufacturer Narrative

Please note that a correction was made to the following section(s): the event occurred on (b)(6) 2014.

• Brand Name: VELOCITY DELIVERY MICROCATHETER
• Type of Device: DQY
• 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: 4743937
• MDR Text Key: 5705566
• Report Number: 3005168196-2015-00424
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2015

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 Catalogue Number: VEL160STR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 05/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 74 YR