MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 HI-FLOW KIT; NRY

Catalog Number	5MAXACE132KIT
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system ace 60 hi-flow kit (kit).During the procedure, while using the solumbra technique, the physician retracted the stent retriever back into the penumbra system ace 60 reperfusion catheter (ace60); however, the stent retriever became stuck after retracting a few centimeters into the ace60.The physician then attempted to retract and remove the ace60 and the stent retriever together but both became stuck inside the neuron max 6f 088 long sheath (neuron max).Subsequently, the physician removed the neuron max with both the ace60 and stent retriever from the patient's body.Upon flushing the ace60 outside of the patent's body, a balloon formed in the distal shaft of the ace60.Therefore, the procedure was completed using the same neuron max, a new ace60, and the same stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ace60 was repeatedly kinked approximately 115.5 and 118.0 cm from the hub.There was no balloon visible on the distal shaft of the ace60.Conclusions: evaluation of the returned device revealed that the ace60 distal shaft was repeatedly kinked.This type of damage typically occurs due to improper handling during use.If the stent is forcefully retracted into the ace60 after it became stuck inside the ace60 tip, damage such as this may occur.The root cause of the ace60 and the stent getting stuck in the neuron max could not be determined.During functional analysis, the ace60 was advanced through a demonstration neuron max and out of the distal tip without an issue.The neuron max and stent mentioned in the complaint were not returned for evaluation.There was no balloon visible on the distal shaft of the ace60.Penumbra catheters are visually 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.

• Brand Name: PENUMBRA SYSTEM ACE 60 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7129284
• Report Number: 3005168196-2017-02222
• Device Sequence Number: 1799297
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Followup
• Report Date (Section B): 11/19/2017

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: 02/22/2020
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F74550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 11/19/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1