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

Catalog Number	5MAXACE132
Medical Device Problem Codes	Kinked (1339); Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system 5max ace reperfusion catheter (5max ace) was kinked approximately 3.5 and 74.0 cm from the hub.During functional analysis, a stainless steel mandrel was attempted to be advanced through the 5max ace; however, the mandrel could not be advanced pass the kink in the proximal shaft.Conclusions: evaluation of the retuned device confirmed that the 5max ace was kinked.This type of damage typically occurs due to improper handling during use.If the device is forcefully manipulated at extreme angles during use, damage such as this may occur.If the 5max ace becomes kinked, thrombus aspirated through the catheter shaft may be more likely to become stuck in the kinked region, which may occlude the catheter lumen.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system 5max ace reperfusion catheter (5max ace).During the procedure, the physician placed a non-penumbra balloon guide catheter towards the internal carotid artery (ica), then advanced a non-penumbra microcatheter and the 5max ace coaxially towards the target location.The physician did not mention feeling resistance while advancing the 5max ace.While initiating aspiration with the penumbra system pump max 110v (pump max), the physician noticed that the shaft of the 5max ace became occluded and kinked.Therefore, the 5max ace was removed and the procedure was completed using other devices.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: 7169759
• Report Number: 3005168196-2018-00065
• Device Sequence Number: 1455682
• 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): 12/07/2017

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: 11/18/2019
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F72140
• 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: 12/07/2017
• Initial Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1