MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JETD REPERFUSION CATHETER; NRY

Catalog Number	5MAXJETDKIT
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k)# that also applies to this complaint: k133317.The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system jetd kit (kit).During the procedure, the physician advanced a penumbra system jetd reperfusion catheter (jetd) through a non-penumbra microcatheter.As the jetd neared the left circumflex coronary artery (lcca), the outer layer of the jetd became "crinkled" outside of the rhv, exposing the inner wiring of the jetd.Therefore, the physician attempted to retract the jetd, however, the jetd separated proximally.The procedure was then completed using a penumbra system jet 7 reperfusion catheter, a penumbra system ace 68 reperfusion catheter, a new jetd, and a non-penumbra stent retriever.
Additional Manufacturer Narrative
Results: the returned jetd was fractured at approximately 28.0 cm from the hub.The device was ovalized at approximately 27.0 cm from the hub.Conclusions: evaluation of the returned jetd confirmed a fractured device.If the device is forcefully advanced against resistance, the device may become damaged.Subsequently retracting a damaged catheter against resistance may result in the device becoming fractured.Further evaluation of the returned jetd revealed that the catheter shaft was ovalized.This ovalization was incidental to the reported issue and likely occurred while packaging the device for return to penumbra.Penumbra 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.

• Brand Name: PENUMBRA SYSTEM JETD REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8394808
• Report Number: 3005168196-2019-00413
• Device Sequence Number: 1341282
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K090752
• 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): 02/04/2019
• 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: 02/20/2021
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F81963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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