MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 HI-FLOW KIT; NRY

Catalog Number 5MAXACE068KIT

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system ace 68 reperfusion catheter (ace68) was kinked approximately 68.0 cm from the hub.Conclusions: evaluation of the returned device revealed that the ace68 was kinked.This type of damage typically occurs due to improper handling during preparation.If the device is handled with force during preparation, damage such as this may occur.During functional analysis, a mandrel was advanced through the hub of the ace68; however, the mandrel could not be advanced beyond the kink in the ace68.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 ace 68 hi-flow kit (kit) for a thrombectomy procedure, the radiologic technologist noticed that the distal tip of the penumbra system ace 68 reperfusion catheter (ace68) was crimped.The damaged ace68 was found prior to use in the patient and therefore, the ace68 was not used for the procedure.The procedure was completed using a new kit.

• Brand Name: PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
• 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: 6884441
• MDR Text Key: 89264227
• Report Number: 3005168196-2017-01622
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F72938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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