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

Catalog Number 5MAXACE132

Device Problems Difficult to Insert (1316); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.

Event Description

The patient was undergoing a thrombectomy procedure in the right internal carotid artery (ica) using a penumbra system ace 60 reperfusion catheter (ace 60).It was noted that the patient had tortuous anatomy.During the procedure, the physician had difficulty inserting the ace 60 into the lesion using a neuron max 6f 088 long sheath (neuron max).Therefore, the physician removed the ace 60 and noticed that there was a kink on the proxmial shaft of the ace 60.The physician then decided to abort the procedure.There was no damage to the neuron max and there was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER
• 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: 6774567
• MDR Text Key: 82068412
• Report Number: 3005168196-2017-01351
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548017426
• UDI-Public: 00814548017426
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/12/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F74953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• 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
• Patient Age: 51 YR