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

Catalog Number	5MAXACE132
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2017
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.This report is associated with mfr report number: 3005168196-2017-01114.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using penumbra system 3max reperfusion catheters (3maxc) and penumbra system 5max ace reperfusion catheters (5max ace).During the procedure, the physician placed a non-penumbra balloon catheter in the target vessel.Next, the physician advanced a non-penumbra guidewire through a 3maxc, then attempted to advance the 3maxc into the 5max ace; however, the physician felt that it was not smooth but somehow was able to advance the 3maxc through the 5max ace.While attempting to co-axially advance the 5max ace through the non-penumbra balloon catheter, the physician experienced resistance and the 3maxc and 5max ace would not advance.Therefore, the physician removed the 3maxc and the 5max ace.The procedure was then completed using a new 3maxc and the 5max ace and the same balloon catheter without further issues.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: there was no visible damage to the penumbra system 5max ace reperfusion catheter (5max ace).The maximum outer diameter (od) of the 5max ace was measured and found to be within specification.The exterior of the 5max ace was checked for lubricity during decontamination, and lubricity was present on the 5max ace.Conclusions: evaluation of the returned devices revealed there were no issues while advancing the devices.The 3maxc was able to advance through the 5max ace without issue.The 5max ace and 3maxc were coaxially advanced into a demonstration neuron max without issue.The ods of each device were within specification, and lubricity was present on the exteriors of the devices.Therefore, the root cause of the reported difficulty advancing could not be determined.The non-penumbra balloon catheter mentioned in the complaint was not returned for evaluation.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2017-01114.

• 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: 6694761
• Report Number: 3005168196-2017-01115
• Device Sequence Number: 16455530
• 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,Followup
• Report Date (Section B): 06/08/2017

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: 02/06/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F74243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1