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

Catalog Number	5MAXACE068KIT
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ace68 was kinked approximately 59.0 cm from the proximal end.Conclusions: evaluation of the returned device confirmed the ace68 was kinked.If the ace68 is withdrawn from the packaging prior to removing the tubing tray from the kit retainer, damage such as this may occur.Penumbra catheters are inspected during in-process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 or Problem Description
During preparation for a thrombectomy procedure, the hospital staff noticed that the penumbra system ace 68 reperfusion catheter (ace68) was kinked upon removal from the packaging of the penumbra system ace 68 hi-flow kit (kit).The damaged ace68 was found prior to use and therefore; it was not used in the procedure.The procedure was completed using a new ace68.

• Brand Name: PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7240823
• Report Number: 3005168196-2018-00241
• Device Sequence Number: 1223301
• Product Code: NRY
• UDI-Device Identifier: 00814548016597
• UDI-Public: 00814548016597
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F72344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005