MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER; NRY

Model Number 5MAXACE132-A

Device Problems Suction Problem (2170); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60).It was reported that the patient anatomy was tortuous.During the procedure, the physician completed two successful passes in the target vessel using the ace60.Then, during the third pass, it was noticed that no thrombus was being aspirated out after some time; therefore, physician decided to remove the ace60.After the removal of the ace60, it was noticed that 5-10 centimeters from the distal end of the ace60 was ovalized.The procedure was completed using a new ace60.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the returned ace60 was ovalized at approximately 116.0 ¿ 126.0 cm from the hub.Conclusions: evaluation of the returned ace60 confirmed an ovalization on its distal shaft.If the rhv used in the procedure is not fully opened during retraction of the ace60, and subsequently, the ace60 is retracted through the rhv at an extreme angle, damage such as an ovalization may occur.During functional testing, the returned ace60 was unable to be advance through a demonstration neuron max due to the ovalization.Penumbra catheters are 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

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60), a non-penumbra short sheath and a non-penumbra long sheath.It was reported that the patient anatomy was tortuous.During the procedure, the physician completed two successful passes in the target vessel using the ace60, short sheath and long sheath.Then, during the third pass, it was noticed that no thrombus was being aspirated out after some time; therefore, physician decided to remove the ace60.After the removal of the ace60, it was noticed that 5-10 centimeters from the distal end of the ace60 was ovalized.The procedure was completed using a new ace60, the same short sheath and the same long sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by the sales representative on (b)(6)2020 : section b.Box 5.Describe event or problem section e.Box 1.First name section e.Box 2.Last name h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9966332
• MDR Text Key: 187938463
• Report Number: 3005168196-2020-00559
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548017426
• UDI-Public: 00814548017426
• 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,Followup
• Report Date: 01/01/2005,03/22/2020

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: 04/28/2022
• Device Model Number: 5MAXACE132-A
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F89930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• 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: 03/22/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 05/27/2020; 05/31/2020
• Supplement Dates FDA Received: 06/02/2020; 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR