MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE132
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the penumbra system 5max ace reperfusion catheter (5max ace) was fractured approximately 1.0 cm from the hub.The penumbra investigator unintentionally ovalized the 5max ace approximately 132.0 cm from the hub when flushing the catheter.Conclusions: evaluation of the returned catheter confirmed a fracture near the proximal hub.The 5max ace was reportedly kinked upon removal from packaging.This type of damage is likely a result of forceful manipulation at extreme angles during removal from the packaging hoop.The continued use of a kinked catheter, as described in the complaint, will likely result in a fracture of the catheter shaft.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
The patient was undergoing a thrombectomy procedure using a penumbra system 5max ace reperfusion catheter (5max ace).During the procedure, prior to use, the physician noticed that the 5max ace was kinked at the strain relief and became "weak" upon removal from the packaging.However, the physician did not have another 5max ace to use right away and decided to use the kinked 5max ace.While in use with the patient, blood leaked out of the 5max ace.Therefore, the 5max ace was removed and the procedure was completed using a new 5max ace.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6707110
• Report Number: 3005168196-2017-01143
• Device Sequence Number: 1571089
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2017

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: 01/17/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F73821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1