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

Catalog Number 3MAXC

Device Problems Fracture (1260); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system 3max reperfusion catheter (3max) was fractured approximately 29.5 cm from the hub.The 3max catheter shaft was twisted.Conclusions: evaluation of the returned device confirmed that the 3max was fractured.This type of damage typically occurs due to improper handling during removal from the packaging.If the device is forcefully retracted an extreme angles during removal from its packaging hoop, damage such as this may occur.Further evaluation revealed that the distal shaft of the 3max was twisted.This damage was likely incidental and likely occurred while handling the device after it was removed from its packaging.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.

Event Description

During preparation for a thrombectomy procedure, the hospital staff opened and handed off the penumbra system 3max reperfusion catheter (3max) to the physician.Upon being handed the 3max, the physician noticed that the 3max was fractured about thirty centimeters from its the proximal end.The damaged 3max was found prior to use and therefore, was not used in the procedure.The procedure was successfully completed using another microcatheter.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 1.Usage of device.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6993447
• MDR Text Key: 91539306
• Report Number: 3005168196-2017-01905
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012490
• UDI-Public: 00814548012490
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/04/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2019
• Device Catalogue Number: 3MAXC
• Device Lot Number: F72871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 11/01/2017
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1