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)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the psr3d delivery wire was kinked 82.0, 114.0, and 171.0 cm from the proximal end.The proximal end of the stent component was bent.Conclusions: evaluation of the returned psr3d revealed the delivery wire was kinked and the proximal end of the stent component was bent.This damage likely occurred due to forceful manipulation of the psr3d against resistance.The tortuous patient anatomy mentioned in the complaint likely contributed to this resistance experienced when advancing both psr3ds, and likely contributed to the damage observed throughout the returned psr3d.During functional testing, the returned psr3d was advanced through a demonstration 3maxc, with some resistance experienced when advancing the 82 cm kink into the 3maxc lumen.The 3maxc and second psr3d mentioned in the complaint were not returned for evaluation.Penumbra coils and 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.This report is associated with mfr report number: 3005168196-2018-00518, 3005168196-2018-00541.
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) and a penumbra system 3max reperfusion catheter (3maxc).It was noted that the patient¿s anatomy was very tortuous.During the procedure, while attempting to track a psr3d through a 3maxc, the physician experienced resistance and subsequently, the psr3d would not advance and became bent; therefore, it was removed.The physician then attempted to advance a new psr3d through the 3maxc; however, the second psr3d would not track either.Therefore, the 3maxc and psr3d were removed and the procedure was ended at that point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2018-00518 and 3005168196-2018-00541.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2018-00518 and 3005168196-2018-00541.

• 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: 7332478
• Report Number: 3005168196-2018-00517
• Device Sequence Number: 11149056
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2018
• 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: 06/29/2020
• Device Catalogue Number: PSR3D
• Device Lot Number: F77985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 11/13/2018; 09/09/2019; 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005