MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE064-A
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	04/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the product display box was crushed and folded on one side.The penumbra system ace 64 reperfusion catheter (ace 64) was kinked underneath the strain relief, approximately 1.0 from the hub.The ace 64 was kinked approximately 20.0, 20.5, and 89.0 cm from the hub.Conclusions: evaluation of the returned device revealed that it was kinked in multiple locations along the catheter shaft.Further evaluation revealed that the product display box was crushed and folded on one side.The damage noted on the product display box and ace 64 may have occurred due to improper handling during transit, or due to improper storage of the device.This observed damage on the display box may have caused the ace 64 inside the box to become damaged.Some of the kinks observed on the ace 64 were likely incidental, and may have occurred during packaging of the device for return.Penumbra catheters and product boxes are 100% visually inspected during in-process inspection.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 physician noticed that the penumbra system ace 64 reperfusion catheter (ace 64) was kinked upon removal from the packaging.The kinked ace 64 was noticed prior to use and therefore, was not used for the procedure.The procedure was completed using a new ace 64.

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5654824
• Report Number: 3005168196-2016-00669
• Device Sequence Number: 27239
• Product Code: NRY
• UDI-Device Identifier: 00814548016207
• UDI-Public: 00814548016207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152541
• 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
• Report Date (Section B): 04/15/2016

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: 09/20/2018
• Device Catalogue Number: 5MAXACE064-A
• Device Lot Number: F65761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2016
• Initial Report FDA Received Date: 05/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1