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

Catalog Number 3MAXC

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 05/05/2016

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2016-00772, 3005168196-2016-00773.

Event Description

The patient was undergoing a thrombectomy procedure for an acute-stage cerebral infarction using a penumbra system 3max reperfusion catheter (3max) and a penumbra system 5max ace reperfusion catheter (5max ace).During preparation for the procedure, the physician noticed that the 3max was already damaged and its blade was completely exposed upon removal from the packaging hoop.The damaged 3max was found prior to use and therefore, was not used for the procedure.The physician then opened a new 3max for the procedure and advanced it to the target vessel while inserting another manufacturer's guiding balloon catheter into the internal carotid artery (ica).Next, the physician started to aspirate the thrombus using the 3max and 5max ace; however, aspiration was not sufficient enough to completely remove the thrombus.Therefore, a stent retriever was advanced through the 5max ace in order to completely remove the thrombus.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Result: the penumbra system 3max reperfusion catheter (3max) was fractured approximately 9.0 cm from the hub.Conclusion: evaluation of the returned device revealed that the 3max was fractured.This type of damage typically occurs due to improper handling during preparation for use.If the 3max is forcefully manipulated or handled at extreme angles, damage such as this may occur.Penumbra catheters are 100% visually evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5717185
• MDR Text Key: 47210698
• Report Number: 3005168196-2016-00771
• 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,Followup
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 3MAXC
• Device Lot Number: F66486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• 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