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

Catalog Number	5MAXJETDKIT
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.Additional 510(k) # k133317.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jetd kit.During the procedure, the physician made an initial pass using a non-penumbra stent retriever through the penumbra system jetd reperfusion catheter (jetd) and a neuron max 6f 088 long sheath (neuron max).While removing the stent retriever, it was ¿hung up¿ inside of the jetd, causing the jetd to stretch; therefore, the jetd and was removed.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68), with a penumbra system 3max reperfusion catheter (3maxc), the same sheath, and another stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned jetd was kinked at approximately 112.0 cm from the hub.The total length of jetd was measured to be approximately 137.0 cm from the hub.Conclusion: evaluation of the returned jetd revealed a damaged region on its distal length.If the non-penumbra stent retriever became stuck within the jetd lumen and was then forcefully retracted, the jetd may compress and become damaged.The non-penumbra stent retriever was not returned for evaluation and the root cause of it becoming stuck within the jetd could not be determined.During functional testing, a demonstration psr3d was able to be delivered through the jetd within minor resistance experienced at the damaged region.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: 8248282
• Report Number: 3005168196-2019-00092
• Device Sequence Number: 2189801
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018
• 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: 10/03/2021
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F86247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005