MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number 4002C0720

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

Patient Problem Ischemia (1942)

Event Date 12/19/2013

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.Potential adverse events in the labeling with the penumbra system include, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated complications.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2015-00855.

Event Description

The patient was undergoing a coil embolization procedure in the internal carotid artery using penumbra coil 400 (pc400) coils.The procedure was successful with no complications.However, the next day, magnetic resonance imaging revealed small foci of silent ischemia in the left cerebral hemisphere of the patient.The relationship of the pc400 coils to the ischemia is uncertain; however the relationship of the procedure to the ischemia is definite.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 8905884
• MDR Text Key: 154725475
• Report Number: 3005168196-2019-01583
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010540
• UDI-Public: 00814548010540
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 4002C0720
• Device Lot Number: F38122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/30/2015
• Initial Date FDA Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 47 YR