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

Catalog Number	PSR3D
Medical Device Problem Codes	Bent (1059); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the distal portion of the psr3d was twisted and the spiral switches direction approximately 1/3 into its length.The psr3d struts were intact at the attachment tip.The device advanced through a demonstration 3max and out of the distal tip with some resistance.The demonstration 3max took the spiraled shape of the psr3d.Significant resistance was experienced while retracting.The catheter had to be supported to get the psr3d to pull back through.Conclusions: evaluation of the returned psr3d revealed a bent region of the distal delivery wire.This damage may have been a result of placing the device in difficult, tortuous anatomy.During functional testing, the device was able to be advanced through the length of a demonstration 3max catheter.Some resistance was experienced was when retracting the device.The bends in the distal delivery wire likely contributed to the resistance experienced during the subject procedure and functional testing.Penumbra psr3ds are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 and m2 segments of the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).During the procedure, the physician made one pass using a penumbra system ace 68 reperfusion catheter (ace68).The physician then advanced a psr3d to the m2 through a non-penumbra microcatheter.The physician was unable to advance the ace68 to the m2 and therefore left the ace68 at the ophthalmic artery origin.After about five minutes, the physician attempted to retract and remove the psr3d, however, felt resistance and was unable to.It was reported that the psr3d felt caught on something within the patient; however, the physician was able to remove the psr3d after forcefully pulling it.Upon removal, it was noted that the pusher assembly of the psr3d was bent.It was reported that there was no stenosis in the vessel, and the clot was still in place after the removal of the psr3d.The procedure was then completed using the same ace68 and a non-penumbra stent retriever.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: 7589099
• Report Number: 3005168196-2018-01156
• Device Sequence Number: 11059468
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 05/13/2018
• 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 Catalogue Number: PSR3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/13/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005