MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA 5MAX DDC DISTAL DELIVERY CATHETER; DQY

Model Number	5MAXDDC125
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing an embolization procedure in the internal carotid artery (ica) using a penumbra 5max ddc distal delivery cather (5max ddc), a neuron max 6f 088 long sheath (neuron max), a non-penumbra microcatheter, and a non-penumbra embolization device.During the procedure, the physician placed the neuron max, then advanced the 5max ddc and microcatheter through the neuron max.While advancing the embolization device through the microcatheter, the pusher wire of the embolization device became stuck inside the microcatheter.The physician believed that the rotating hemostasis valve (rhv) that was attached to the neuron max was tightly connected to the 5max ddc, causing it to clamp down on the microcatheter and the embolization device.Therefore, the physician removed the 5max dcc, microcatheter and embolization device.The procedure was completed using a new 5max dcc, a new microcatheter, a new embolization device, and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 5max ddc was ovalized approximately 26.0, 29.0, 33.0, 61.5, 6.5 and 116.0 ¿ 117.0 cm from the hub.The device was kinked approximately 18.0, 66.0 and 96.0 cm from the hub.Conclusions: evaluation of the returned 5max ddc confirmed an ovalization on the proximal shaft.If the rotating hemostasis valve (rhv) is overtightened onto the device, damage such as an ovalization may occur.Further evaluation revealed additional ovalizations and kinks along the length of the device.These damages were likely incidental to the reported complaint.No other devices associated with the complaint were returned for evaluation.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.

• Brand Name: PENUMBRA 5MAX DDC DISTAL DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10141569
• Report Number: 3005168196-2020-00752
• Device Sequence Number: 2342294
• Product Code: DQY
• UDI-Device Identifier: 00814548012674
• UDI-Public: 00814548012674
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K122772
• 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: Initial,Followup
• Report Date (Section B): 05/20/2020
• 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: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 5MAXDDC125
• Device Catalogue Number: 5MAXDDC125
• Device Lot Number: F95912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 06/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005