MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER; NRY

Catalog Number	4MAXC
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system 4max reperfusion catheter (4maxc) was ovalized approximately 37.0 cm from the hub.Conclusions: evaluation of the returned devices revealed an ovalization on the 4max mid-shaft and a kink on the px slim mid-shaft.The 4max ovalization may have occurred as a result of mishandling during preparation for use.This ovalization may have caused resistance when attempting to advance the px slim.The px slim kink may have been a result of forcefully advancing the catheter against this resistance.Further evaluation revealed that the px slim strain relief was stretched.This damage is likely a result of forcefully gripping the device while advancing against the previously mentioned resistance.The 5max ace 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.This report is associated with mfr report number: 3005168196-2018-00121.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right m2 segment of the middle cerebral artery (mca) using a px slim delivery microcatheter (px slim) and a penumbra system 4max reperfusion catheter (4maxc).During the procedure, the physician advanced a penumbra system 5max ace reperfusion catheter (5maxace) towards the occluded portion of the right m1 segment and then performed aspiration through the 5maxace.The angiography revealed that the m2 segment was also occluded.Since the 5maxace was not the appropriate size for the target vessel diameter, the physician decided to use the 4maxc instead.While attempting to advance a px slim into the 4maxc, the physician experienced resistance at the proximal part of the 4maxc.Although resistance was encountered, the physician was able to advance the 4maxc into the target vessel and successfully completed the procedure using the same 4maxc.It was reported that there were no observed kinks on the px slim or 4maxc.Additionally, there was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7184349
• Report Number: 3005168196-2018-00120
• Device Sequence Number: 13747605
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• 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): 12/14/2017

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: 08/07/2020
• Device Catalogue Number: 4MAXC
• Device Lot Number: F78539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1