MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 HI-FLOW KIT; NRY

Catalog Number	5MAXACE068KIT
Medical Device Problem Codes	Kinked (1339); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system ace 68 reperfusion catheter (ace68) was kinked approximately 28.0, 79.0, 80.0, and 91.0 cm from the hub.Conclusions: evaluation of the returned ace68 confirmed it was kinked.This damage may have occurred due to forceful manipulation of the ace68 during navigation of patient anatomy or advancement through the neuron max.The observed kink likely contributed to the lack of aspiration reported in the complaint.The neuron max mentioned in the complaint was not returned for evaluation.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 internal carotid artery (ica)/middle cerebral artery (mca) to treat an ischemic stroke using penumbra system ace 68 hi-flow kits (kits).During the procedure, while using a penumbra system ace 68 reperfusion catheter (ace68) with a neuron max 6f 088 long sheath (neuron max), the aspiration stopped working; therefore, the ace68 was removed.Upon removal, the physician noticed that the ace68 was kinked around the mid-shaft.Therefore, the procedure was completed using a new kit and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ace68 was kinked approximately 28.0, 79.0, 80.0, and 91.0 cm from the hub, however; fluid was aspirated through the ace68 without issue."510(k) #¿ to k161640.

• Brand Name: PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6937898
• Report Number: 3005168196-2017-01765
• Device Sequence Number: 1443799
• Product Code: NRY
• UDI-Device Identifier: 00814548016597
• UDI-Public: 00814548016597
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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: 07/14/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F70596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR