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

Catalog Number 5MAXACE068

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system ace 68 reperfusion catheter (ace68) was kinked approximately 35.0 and 76.0 cm from the hub.Conclusions: evaluation of the returned device revealed it was kinked.This damage may have occurred due to forceful manipulation of the ace68 at extreme angles during removal from the packaging.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

During preparation for a thrombectomy procedure, the physician found that the penumbra system ace 68 reperfusion catheter (ace68) was kinked 40cm from the proximal hub upon removal from the packaging.The damage to the ace68 was found prior to use.Therefore the ace68 was not used in the procedure.The procedure was completed using a new ace68.

• Brand Name: PENUMBRA SYSTEM ACE 68 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: 7298103
• MDR Text Key: 101131444
• Report Number: 3005168196-2018-00418
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016535
• UDI-Public: 00814548016535
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161640
• 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,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/03/2020
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: F79827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2017
• 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