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

Catalog Number 5MAXACE068KIT

Device Problems Entrapment of Device (1212); Physical Resistance (2578); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results: the penumbra system ace 68 reperfusion catheter (ace68) was kinked approximately 17.0 cm from the hub and had multiple consecutive kinks beginning approximately 120.0 cm from the hub.There were no visible wires protruding from the ace68, nor was there visible damage to the inner catheter shaft coil.During functional analysis, a 0.068¿ mandrel was inserted into the ace68, but could not be advanced pass the kink located approximately 17.0 cm from the hub.Conclusions: evaluation of the returned device revealed that it was kinked in the proximal shaft and had multiple consecutive kinks in the distal shaft.The distal kinks likely occurred due to forceful retraction of the non-penumbra stent retriever against resistance.The proximal kink may have occurred due to forceful handling of the ace68 during withdrawal of the non-penumbra stent retriever.The non-penumbra stent retriever mentioned in the complaint was not returned for evaluation, and the root cause of the initial resistance experienced during retraction could not be determined.However, if substantial clot is captured within a stent retriever, it may cause difficulty when attempting to withdraw the stent retriever through the ace68.There were no visible wires protruding from the ace 68.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 using a penumbra system ace 68 hi-flow kit (kit).During the procedure, the physician made one pass using a non-penumbra stent retriever through the penumbra system ace 68 reperfusion catheter (ace68).While retracting the stent retriever into the ace68, the physician encountered resistance and decided to remove both of the devices as system.Upon removal and examination of the devices, a small wire from the inside of the ace68 was found to be stuck to the stent retriever and continued to pull from inside the ace68.The procedure ended at this point because the thrombus had been removed with one pass.There was no report of an adverse effect to the patient.

• 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: 6914879
• MDR Text Key: 88232190
• Report Number: 3005168196-2017-01719
• 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: Physician
• Type of Report: Initial
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/19/2020
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F75086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• 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