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

Catalog Number	5MAXACE064
Medical Device Problem Codes	Kinked (1339); No Pressure (2994)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2016
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
The patient was undergoing a thrombectomy procedure using a penumbra system ace 64 reperfusion catheter (ace 64).During the procedure, the physician noticed the ace 64 was kinked around the hub area which then caused false air during aspiration.The physician reported feeling no particular resistance prior to this damage.The kinked ace 64 was removed and the procedure was completed using a new ace 64.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the penumbra system ace 64 reperfusion catheter (ace 64) was fractured approximately 3.0 cm from the hub.The strain relief was partially unwound by a penumbra investigator for further evaluation, and no further damage or abnormalities were present.Conclusion: evaluation of the returned device revealed the ace 64 was fractured.This type of damage typically occurs due to improper handling during preparation or use.If the ace 64 is forcefully removed from the packaging hoop at an angle, or manipulated at extreme angles during insertion into a catheter or sheath, 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: 5660289
• Report Number: 3005168196-2016-00689
• Device Sequence Number: 293350
• Product Code: NRY
• UDI-Device Identifier: 00814548013961
• UDI-Public: 00814548013961
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K152541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2016

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: 07/13/2018
• Device Catalogue Number: 5MAXACE064
• Device Lot Number: F64893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• 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
• Patient Age: 52 YR