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

Catalog Number	PSR3D
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Physical Resistance (2578); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: one of the struts on the proximal end of the penumbra system 3d revascularization device (psr3d) stent was fractured.Conclusions: evaluation of the returned psr3d revealed one of the struts on the proximal end of the stent was broken.This damage was likely a result of forcefully retracting the device against a strong resistance.This resistance likely originated from the attempted retraction of the psr3d back into the non-penumbra microcatheter.If the psr3d is deployed and engages any thrombus it will likely be unable to be retracted back into a microcatheter.Penumbra psr3ds 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 in the m1 segment of the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).During the procedure, the physician advanced a non-penumbra microcatheter through a penumbra system ace68 reperfusion catheter (ace68), then deployed the psr3d through the microcatheter.The physician then noticed that the psr3d was deployed in the wrong position and tried to pull it back into the microcatheter (pinned the microcatheter and pulled the 3d back); however, resistance was encountered and the psr3d could not be pulled any further.Therefore, the physician locked the psr3d down with the rotating hemostasis valve (rhv) that was on the back of the microcatheter and pulled both the psr3d and microcatheter back through the ace68 as one system.Upon removal, the physician noticed that one of the tines was broken and sitting outside of the microcatheter.The procedure was completed using the same ace68, microcatheter and another stent retriever device.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: 7292204
• Report Number: 3005168196-2018-00398
• Device Sequence Number: 16447069
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 01/24/2018
• 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: 08/13/2020
• Device Catalogue Number: PSR3D
• Device Lot Number: F78696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Date Report Sent to FDA: 01/01/2005