MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 HI-FLOW KIT; NRY

Catalog Number 5MAXACE064KIT

Device Problems Break (1069); Fracture (1260); Material Separation (1562)

Patient Problems Infarction, Cerebral (1771); Embolus (1830)

Event Date 04/09/2017

Event Type  Injury  

Manufacturer Narrative

The reported complaint indicated that partial reperfusion was achieved and that the patient still had a large mca infarct and mass effect a day after the procedure.Per the "potential adverse events" listed in the instructions for use, the inability to completely remove thrombus and emboli are possible complications related to revascularization procedures using the penumbra system.Results: the penumbra system ace 64 reperfusion catheter (ace 64) was kinked and stretched approximately 103.0 cm from the hub.The stretched region ended approximately 108.0 cm from the hub, where the ace 64 was fractured.The ace 64 was kinked approximately 110.Cm from the hub.Conclusions: evaluation of the returned ace 64 revealed that it was stretched and fractured.It is possible for the ace 64 to become pinned against patient anatomy or other devices used in the procedure.If the ace 64 becomes pinned and is then forcefully retracted, stretching and fracture damages may occur.Further evaluation revealed that the ace 64 was kinked.This damage may have occurred due to forceful advancement of the ace 64 against resistance.The 3max mentioned in the complaint was not returned for evaluation.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.This report is associated with mfr report number: 3005168196-2017-00702.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3max) and a penumbra system ace 64 hi-flow kit.During the procedure, the physician used the 3max and the penumbra system ace 64 reperfusion catheter (ace 64) for the initial pass to remove thrombus.During the second pass, the 3max became lodged into clot and was stuck in the internal carotid artery (ica).The physician then attempted to remove both the 3max and ace 64.However, the 3max was so lodged that its tip broke off completely.It was also reported that the ace 64 snapped in half approximately fifteen centimeters from the distal tip but was successfully snared out.However, after several failed attempts to snare the tip of the 3max out, the physician decided to leave the tip of the 3max in the patient and stop the procedure.The physician believed that continuing the procedure could cause more harm than good.Partial reperfusion was achieved but the patient still had clot remaining in the vessel.As of (b)(6) 2017, the patient still had a large mca infarct and mass effect.The mass effect was caused by not being able to successfully remove the thrombus in the mca.

• Brand Name: PENUMBRA SYSTEM ACE 64 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: 6554065
• MDR Text Key: 74740981
• Report Number: 3005168196-2017-00701
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016481
• UDI-Public: 00814548016481
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160449
• 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: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/11/2019
• Device Catalogue Number: 5MAXACE064KIT
• Device Lot Number: F70531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 38 YR