MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Model Number 5MAXACE068KIT

Device Problems Break (1069); Migration (4003); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra catheter, non-penumbra microcatheters, and a guidewire.During the procedure, it was reported that the catheter reached as far as the internal carotid artery (ica).When the distal tip of the ace68 reached the c4 segment of the ica, the patient developed a vasospasm in the ica and mca.The relationship between the vasospasm and the ace68 is unknown.It was also reported that the ace68 could not be controlled after passing through the guide catheter; therefore, the physician decided to remove the ace68 containing the non-penumbra microcatheter.Upon removal of the ace68, resistance was encountered.When the ace68 was outside of the patient, the physician noticed that the distal tip was broken off in the mca.The physician decided to leave the ace68 tip inside the patient; therefore, no attempts were made to remove it.Next, the physician attempted to use the same non-penumbra microcatheter to advance a stent retriever into the target location but was unable to reach the occlusion site.Therefore, the devices were withdrawn, and the physician finished the procedure.No attempts were made to remove the tip due to difficulty catheterizing the target vessel and the patient¿s condition being stable.Post-operative imaging revealed that the broken tip had migrated into the m3 segment of the middle cerebral artery (mca).It was reported that the patient recovered with nihss score decreasing from 16 before surgery to 3-5 post-procedure.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were inadvertently missed on the initial mfr report and are being updated on this follow-up # 01 mfr report: 1.Section h.Box 6.Evaluation codes device code 3, 2.Section h.Box 6.Evaluation codes patient code 2.Evaluation of the returned ace68 confirmed a fracture.Further evaluation revealed that the catheter was stretched proximal to the fractured location.This indicated that the device was stretched prior to fracture.If the ace68 is forcefully retracted against resistance during the procedure, damage such as this may occur.The distal fractured segment was not returned for evaluation.The root cause of the resistance could not be determined.Further evaluation revealed a mid-shaft kink.This damage was likely incidental to the complaint.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.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11895080
• MDR Text Key: 253176072
• Report Number: 3005168196-2021-01168
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (y/n): Y
• PMA/PMN Number: K161640
• 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: 01/01/2005,07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 5MAXACE068KIT
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F91488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• 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: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1