MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE; NRY

Catalog Number	PSR3D
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) and middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).During the procedure, the physician made a successful pass using the psr3d with a penumbra system ace 68 reperfusion catheter (ace68) and a neuron max 6f 088 long sheath (neuron max).While attempting to make a second pass with the psr3d, the physician felt resistance and decided to retract the psr3d.However, while retracting, the psr3d unintentionally detached in the terminus segment of the ica.Therefore, the physician used a snare device to successfully remove the psr3d.The procedure was completed using a non-penumbra stent retriever device with the same ace68 and neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the psr3d was fractured off its delivery wire approximately 198.5 cm from the proximal end.The psr3d delivery wire was kinked approximately 63.0 and 64.5 cm from the proximal.Conclusions: evaluation of the returned psr3d revealed that the device was fractured off its delivery wire.If the device is forcefully retracted against resistance, damage such as a fracture may occur.Further evaluation of the returned device revealed that delivery wire was kinked.These kinks were likely incidental to the reported issue and may have occurred due to packaging of the device for return to penumbra.Penumbra devices 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.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2019-01102.1.Section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) and middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).During the procedure, the physician made a successful pass using the psr3d with a penumbra system ace 68 reperfusion catheter (ace68) and a neuron max 6f 088 long sheath (neuron max).While attempting to make a second pass with the psr3d, the physician felt resistance and decided to retract the psr3d.However, while retracting, the psr3d broke off inside the patient''s terminus segment of the ica.Therefore, the physician used a snare device to successfully remove the psr3d.The procedure was completed using a non-penumbra stent retriever device with the same ace68 and neuron max.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8672471
• Report Number: 3005168196-2019-01102
• Device Sequence Number: 2118121
• Product Code: NRY
• UDI-Device Identifier: 00814548017839
• UDI-Public: 00814548017839
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K162901
• 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): 05/08/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2021
• Device Catalogue Number: PSR3D
• Device Lot Number: F87117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005