MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number 5MAXACE132

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the 5max ace was kinked approximately 62.0 cm from the hub.Conclusions: evaluation of the returned device confirmed that the 5max ace was kinked.This type of damage typically occurs due to improper handling during removal from the packaging.If the device is forcefully retracted at an angle from its packaging hoop during removal, damage such as this 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.

Event Description

While preparing a penumbra system 5max ace reperfusion catheter (5max ace) for a thrombectomy procedure, the physician opened the 5max ace packaging and flushed the packaging hoop and 5max ace.Upon removing the 5max ace from its dispenser hoop after the flush, the physician confirmed a kink approximately 60 cm from the proximal end of the 5max ace.The damaged 5max ace was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new 5max ace.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE 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: 6764695
• MDR Text Key: 81742435
• Report Number: 3005168196-2017-01345
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160449
• 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: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/22/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F74549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• 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