MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number 3MAXC

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.

Event Description

The patient was undergoing a thrombectomy procedure for an acute stage cerebral infarction in the m2 section of the internal carotid artery (ica) using a penumbra system 3max reperfusion catheter (3max).It was reported that the m2 was curved like a right angle but not tortuous.During the procedure, the physician used the 3max with the penumbra system 5max ace reperfusion catheter (5max ace) to perform three passes using the adapt (a direct aspiration first pass) technique.The physician did not encounter any resistance while using the 3max and 5max ace.After completion of the third pass, the physician removed the 3max from the patient's body and did not notice that the 3max was fractured at this time.The physician then removed the 5max ace from the patient's body and attempted to flush the 5max ace for a fourth pass.While flushing the 5max ace, the physician confirmed that the 3max was fractured as he noticed the tip of the 3max being flushed out of the 5max ace.The physician then decided to end the procedure at this point.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6091481
• MDR Text Key: 59572497
• Report Number: 3005168196-2016-01600
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012490
• UDI-Public: 00814548012490
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/08/2019
• Device Catalogue Number: 3MAXC
• Device Lot Number: F70037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1