MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Model Number 5MAXACE068KIT

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

Patient Problem Vascular Dissection (3160)

Event Date 01/24/2021

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the penumbra system include, but are not limited to, dissection, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, vessel spasm, thrombosis, ischemia, including death.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

On (b)(6) 2021, the patient underwent a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra microcatheter, and a stent retriever.After one pass using the ace68 and stent retriever, recanalization was successfully achieved with a thrombolysis in cerebral infarction (tici) grade of 2b.No procedural complications were reported.On (b)(6) 2021, the patient developed subarachnoid hemorrhage (sah) caused by dissection of the left internal carotid artery (ica).No further treatment was conducted per wishes of the patient's family and the patient later expired.It was reported that the ace68 and stent retriever were related to the vessel dissection.The cause of the death is unknown.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Type of Device: NRY
• 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: 11704563
• MDR Text Key: 247728809
• Report Number: 3005168196-2021-00817
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/24/2021

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: Health Professional
• Device Expiration Date: 06/12/2022
• Device Model Number: 5MAXACE068KIT
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F90942
• 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: 03/24/2021
• Initial Date FDA Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2019
• 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: 80 YR