MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA 5MAX DDC DISTAL DELIVERY CATHETERS; NRY

Catalog Number	5MAXDDC115
Medical Device Problem Codes	Break (1069); Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the 5max ddc was fractured approximately 5.0 cm from the hub.The 5max ddc was kinked approximately 2.0, 25.0, and 59.0 cm from the hub.The 5max ddc was ovalized approximately 7.0, 114.0, and 116.0 cm from the hub.Conclusions: evaluation of the returned 5max ddc revealed a fracture on its proximal end.This damage is likely a result of forcefully advancing the device against resistance at extreme angles.Further evaluation revealed kinks and ovalizations along the length of the returned catheter.These damages were likely incidental and may have occurred during packaging for return to penumbra.The neuron max referred to in the complaint was not returned for evaluation.Penumbra coils 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 penumbra 5max ddc distal delivery catheters (5max dcc's).During the procedure, while in use with a neuron max 6f 088 long sheath (neuron max), the physician was attempting to advance a 5max dcc into the patient; however, the 5max ddc split and broke in half approximately an inch from the hub; therefore, it was removed.The procedure was completed using another 5max ddc.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA 5MAX DDC DISTAL DELIVERY CATHETERS
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7261807
• Report Number: 3005168196-2018-00316
• Device Sequence Number: 16440258
• Product Code: NRY
• UDI-Device Identifier: 00814548012667
• UDI-Public: 00814548012667
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018
• Report Date (Section F): 01/01/2005

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: 06/30/2018
• Device Catalogue Number: 5MAXDDC115
• Device Lot Number: F64505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005