MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE132
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	06/04/2017
Type of Reportable Event	Serious Injury
Additional 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.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Intracranial hemorrhage 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.The hospital discarded the device.
Event or Problem Description
The patient underwent a thrombectomy procedure in the middle cerebral artery (mca) on (b)(6) 2017 using a penumbra system 5max ace reperfusion catheter (5max ace).It was noted that the patient's anatomy was slightly tortuous.During the procedure, the physician attempted to use two non-penumbra devices, however was unable to remove the thrombus; therefore, the physician attempted to use the 5max ace.The physician was then unable to remove the thrombus and, therefore, the 5max ace was removed.During the final angiography, it was found that there was bleeding inside the patient from the occluded location; therefore, the patient underwent a craniotomy, and the procedure then ended.As of (b)(6) 2017, the patient's mrs was 5.As of (b)(6) 2017, the patient's condition is unknown.The 5max ace has an uncertain relationship to the intracranial hemorrhage.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6812078
• Report Number: 3005168196-2017-01410
• Device Sequence Number: 16578225
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2017

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
• Operator of Device: Physician
• Device Expiration Date: 01/17/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F73821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 52