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

Catalog Number PSR3D

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Patient Involvement (2645)

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

Results: dried blood was observed throughout the penumbra system 3d revascularization device (psr3d).The delivery wire was kinked approximately 162.0 and 171.0 cm from the proximal end.Conclusions: evaluation of the returned device revealed it was removed from its packaging hoop and the packaging hoop was not returned for evaluation.The psr3d was re-loaded into a demonstration packaging hoop and removed from the packaging hoop without issue.Therefore, the root cause of the reported issue could not be determined.Further evaluation revealed the delivery wire was kinked and dried blood was observed throughout the psr3d.Since the psr3d was reportedly not used in the procedure, the root cause of this damage and blood could not be determined.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 Description

During preparation for a thrombectomy procedure, a penumbra system 3d revascularization device (psr3d) would not come out of the dispenser hoop.The issue with the psr3d occurred prior to use and therefore, the psr3d was not used in the procedure.The procedure was completed using a new psr3d.

• Brand Name: PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7354708
• MDR Text Key: 103171967
• Report Number: 3005168196-2018-00601
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (y/n): Y
• PMA/PMN Number: K162901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/16/2020
• Device Catalogue Number: PSR3D
• Device Lot Number: F78719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1