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

Catalog Number	5MAXACE132
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the 5max ace distal shaft was compressed in multiple areas along its length.The 5max ace distal shaft displayed some slight bends.Conclusions: evaluation of the returned 5max ace revealed a slightly damaged distal shaft.If the reported strong torque and force was loaded onto the subject 5max ace and it was subsequently manipulated forcefully in difficult patient anatomy, damage such as these small compressions may occur.Further evaluation revealed slight bends on the distal shaft.These bends are likely due to placement in difficult patient anatomy.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the distal right m1 segment of the middle cerebral artery (mca) using a penumbra system 5max ace reperfusion catheter (5max ace).During the procedure, the physician attempted to aspirate the thrombus using the 5max ace; however, complete revascularization was no achieved.Therefore, the physician attempted to coaxially advance a non-penumbra microcatheter through the 5max ace; however, the catheters would not advance after reaching the ophthalmic artery.It was reported that strong torque and force was loaded onto the 5max ace.The physician then simultaneously advanced another microcatheter and stent retriever device through the 5max ace in order to capture the thrombus.Upon deploying the stent retriever, the physician was able to pass the 5max ace over the ophthalmic artery and into the treatment site in m1.Subsequently, the thrombus was completely aspirated and the 5max ace was removed.Upon removing the 5max ace, it was noted that the 5max ace was deformed.It is unknown if the 5max ace became kinked, stretched or twisted, there was no report of an adverse effect to the patient.

• 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: 7176612
• Report Number: 3005168196-2018-00090
• Device Sequence Number: 19285808
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/11/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F79463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR