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

Catalog Number	5MAXJETDKIT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
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 in the right m1 segment of the middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd).During the procedure, the physician made a successful pass using a jetd, a non penumbra stent retriever, and a non penumbra microcatheter.Before making a second pass, the physician noticed the microcatheter to be damaged and; therefore, it was removed from the patient.The physician attempted to insert a new microcatheter for a second pass; however, was unable to advance the microcatheter and guidewire through the jetd.It was discovered that the tip of the initial microcatheter had broken off and traveled distally.It was reported that the physician did not want to lose access and decided to aspirate using the jetd.The jetd was then removed from the patient and found the distal end of the jetd to be kinked.The procedure was ended at this point and the broken tip of the initial microcatheter was left in the patient as it was too distal in the anatomy to be retrieved.
Additional Manufacturer Narrative
Results: the returned penumbra system jetd reperfusion catheter (jetd) was kinked at approximately 3.0 cm and 123.0 cm from the hub.Conclusions: evaluation of the returned jetd confirmed a distal kink.If the jetd is manipulated against resistance, damage such as a kink may occur.This kink may have contributed to the first microcatheter becoming fractured and the difficulty advancing of the second microcatheter into the jetd.During functional testing, a test mandrel was unable to be advanced pass the kink on the jetd.No other devices associated with the complaint were returned for evaluation; therefore, the root cause of the kink could not be determined.Further investigation revealed an additional kink under the strain relief.This kink was likely incidental to the complaint.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: 9269629
• Report Number: 3005168196-2019-02033
• Device Sequence Number: 13921526
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 10/03/2019
• 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: 01/14/2022
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F87966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 97
• Date Report Sent to FDA: 01/01/2005