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

Catalog Number	5MAXACE132
Medical Device Problem Codes	Collapse (1099); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max) and a penumbra system 5max ace reperfusion catheter (5max ace).It should be noted that the patient¿s anatomy was very tortuous.During the procedure, the physician attempted to advance the 5max ace into the target vessel through the neuron max, but felt resistance.The physician then noticed that the neuron max had become bent.As a result, the 5max ace had stretched and collapsed.Therefore, the physician removed both the neuron max and the 5max ace.Resistance was experienced while retracting the devices for removal.The procedure was completed using a new guide catheter and a new reperfusion catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 5maxace was stretched at approximately from 106.0 cm to 179.0 cm from the hub.The total length of the device was 179.0 cm.Conclusion: evaluation of the returned neuron max revealed a kink on its distal shaft.If the device is forcefully advanced into the reported tortuous patient anatomy the device may become kinked.Further investigation revealed additional kinks on the catheter proximal shaft.These damages were likely incidental to reported complaint and may occur during packaging for return to penumbra.Evaluation of the returned 5maxace revealed a stretching on its distal shaft.This damage is typically a result of forcefully retracting the device against resistance.The resistance was likely caused by the distal kink on the returned neuron max.If neuron max was kinked, the 5maxace could be pinned within the kinked neuron max.Subsequently retracting the pinned 5maxace likely resulted in the device becoming stretched.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.This report is associated with mfr report number: 3005168196-2018-02388.

• 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: 8144683
• Report Number: 3005168196-2018-02389
• Device Sequence Number: 1887257
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 11/09/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 09/14/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F79533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Date Report Sent to FDA: 01/01/2005