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

Catalog Number	PSC054
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	05/14/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system 5max reperfusion catheter (5max) was fractured approximately 53.0 cm from the hub.Conclusions: evaluation of the returned device confirmed that the 5max was fractured.This type of damage typically occurs due to improper handling during removal from packaging.If the 5max is removed from the packaging hoop forcefully or at an angle, the shaft may fracture due to excess force and bending.These devices are 100% visually inspected for damage during process inspection.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 hospital staff noticed that the penumbra system 5max reperfusion catheter (5max) was fractured.The fractured 5max was found prior to use and therefore, was not used for the procedure.The procedure was completed using another manufacturer's catheter.

• Brand Name: PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5877551
• Report Number: 3005168196-2015-00593
• Device Sequence Number: 269573
• Product Code: NRY
• UDI-Device Identifier: 00814548012742
• UDI-Public: 00814548012742
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2015

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: 03/31/2018
• Device Catalogue Number: PSC054
• Device Lot Number: F62962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2015
• Initial Report FDA Received Date: 08/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1