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

Catalog Number	5MAXACE064-A
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2015
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, while doing a pass, the ace 64 was being retracted and became stretched.The physician removed the ace 64 from the patient and completed the procedure using a new penumbra system 5max reperfusion catheter (5max).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 kinked in multiple locations throughout its length and stretched from approximately 102.0 cm from the hub to the distal tip.Conclusion: evaluation of the returned device confirmed that the ace 64 was stretched.This type of damage typically occurs due to improper handling during use.If the ace 64 is forcefully retracted against resistance, damage such as this may occur.Further evaluation revealed the ace 64 was kinked and ovalized in multiple locations throughout its length.This damage likely occurred due to forceful manipulation of the ace 64 during use, or during packaging for return.Ace 64 devices are 100% visually evaluated 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: 5367677
• Report Number: 3005168196-2016-00049
• Device Sequence Number: 16190733
• Product Code: NRY
• UDI-Device Identifier: 00814548016207
• UDI-Public: 00814548016207
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Followup
• Report Date (Section B): 12/16/2015

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: 05/17/2018
• Device Catalogue Number: 5MAXACE064-A
• Device Lot Number: F64367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2016
• Supplement Report FDA Received Date: 02/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR