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	03/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff noticed that the penumbra system ace 64 reperfusion catheter (ace 64) was kinked at the hub upon removal from the dispenser hoop.The kinked ace 64 was found prior to use and was not used for the procedure.The procedure was completed using a new ace 64.
Additional Manufacturer Narrative
Result: the penumbra system ace 64 reperfusion catheter (ace 64) strain relief was offset approximately 2.0 cm from the hub.The strain relief was partially unwound by a penumbra investigator for further evaluation, and the catheter shaft was kinked.Conclusion: evaluation of the returned device revealed the ace 64 was kinked under the strain relief.This type of damage typically occurs due to improper handling during preparation.If the ace 64 if forcefully withdrawn at extreme angles during removal from the packaging hoop, damage such as this may occur.Ace 64 devices are 100% visually inspected during in-process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.

• 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: 5577147
• Report Number: 3005168196-2016-00491
• Device Sequence Number: 16209560
• Product Code: NRY
• UDI-Device Identifier: 00814548016207
• UDI-Public: 00814548016207
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 03/18/2016

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: Health Professional
• Device Expiration Date: 09/08/2018
• Device Catalogue Number: 5MAXACE064-A
• Device Lot Number: F65616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2016
• Supplement Report FDA Received Date: 08/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1