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

Catalog Number	5MAXACE132
Medical Device Problem Codes	Fracture (1260); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system 5max ace reperfusion catheter (5max ace) was fractured approximately 94.5 cm from the hub.The strain relief was slightly kinked and the catheter shaft proximal to the fractured segment had a stress mark.Conclusions: evaluation of the returned device confirmed that the 5max ace was fractured.This type of damage likely occurs due to forceful handling during removal of the device from the packaging hoop.Further evaluation revealed that the strain relief was slightly kinked, and the catheter shaft proximal to the fractured segment had a stress mark.The kinked strain relief and stress mark proximal to the fractured segment suggests that the device may have been forcefully removed from its packaging hoop at an angle.Penumbra catheters are visually 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
During preparation for a thrombectomy procedure, the physician noticed that the penumbra system 5max ace reperfusion catheter (5max ace) was fractured approximately forty centimeters from its tip upon removal from the packaging hoop.The fractured 5max ace was noticed prior to use, and therefore, was not used in the procedure.The procedure was completed using a new 5max ace.

• 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: 6389644
• Report Number: 3005168196-2017-00305
• Device Sequence Number: 735647
• 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): 02/06/2017

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: 09/02/2019
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F71472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1