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

Catalog Number 4MAXC

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2019

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 number: 3005168196-2019-00372.

Event Description

During preparation for a medical procedure, two penumbra system 4max reperfusion catheters (4maxcs) broke in two parts upon removal from the packaging.The damage to the two 4maxcs occurred prior to use and, therefore, were not used in the procedure.The procedure was completed using a new 4maxc.

Manufacturer Narrative

Results: the first evaluated 4maxc was fractured approximately 53.5 cm from the hub.Conclusions: evaluation of the first and second returned 4maxcs revealed that both catheters were fractured.The first evaluated 4maxc was fractured in the proximal shaft.The second evaluated 4maxc was fractured underneath the strain relief.If the devices were forcefully retracted from their packaging at an extreme angle, damage such as a fracture may occur.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.This report is associated with mfr report number: 3005168196-2019-00372.

• Brand Name: PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8376383
• MDR Text Key: 137372414
• Report Number: 3005168196-2019-00371
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2021
• Device Catalogue Number: 4MAXC
• Device Lot Number: F84795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1