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

Catalog Number	PSR3D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the delivery wire was bent approximately 196.0 cm from the proximal end.The coil on the delivery wire was offset approximately 198.0 cm from the proximal end.One leg of the psr3d was fractured distal to the attachment tip.During functional test, resistance was encountered while attempting to remove the introducer sheath and large amount of dried blood was found.Conclusions: evaluation of the returned psr3d revealed a single strut fracture.If the device is forcefully retracted against resistance, this may contribute to the reported failure.If the device were mishandled during preparation, this may also contribute to the reported failure.The velocity identified in the procedure was not returned for evaluation.The root cause of the single strut fracture could not be determined.Further evaluation revealed a bend on the distal length of the delivery wire, which was likely incidental to the reported complaint.Penumbra revascularization devices 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 middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).During the procedure, the physician inserted the psr3d through the velocity delivery microcatheter (velocity) and decided to withdraw it to reposition the velocity.While re-sheathing the psr3d, the physician noticed one of the legs had separated from the pusher assembly.The procedure was therefore completed using a new psr3d and the same velocity.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report.1.Section h.Box 6.Results code 1 h3 other text : placeholder.

• 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: 8228946
• Report Number: 3005168196-2019-00034
• Device Sequence Number: 16650974
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 12/10/2018
• 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: Health Professional
• Device Expiration Date: 04/04/2021
• Device Catalogue Number: PSR3D
• Device Lot Number: F82696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 01/08/2019
• 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: 55 YR
• Date Report Sent to FDA: 01/01/2005