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

Model Number	5MAXJETDKIT
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned jetd revealed that the catheter was fractured, and the complaint was confirmed.The probable cause of the reported failure was likely due to mishandling during use.If the jetd is advanced at an extreme angle during use, damage such as a kink and subsequent fracture may occur.Penumbra products are visually 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 or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system jetd reperfusion catheter (jetd), a non-penumbra microcatheter, and a non-penumbra guiding sheath.During the procedure, the physician placed the guiding sheath in the vertebral artery.Then, before advancing the jetd into the rotating hemostasis valve (rhv), the physician broke the proximal end of the jetd.It was reported that the y connector was not tighten.Subsequently, the guidewire within the jetd bent.Therefore, the jetd and guidewire were removed together.The procedure was completed by making two passes using a penumbra system 3max reperfusion catheter (3maxc).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: 3005168196-2021-02415.Additional 510(k)# that also apply to this complaint: (b)(4) h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM JETD REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12712082
• Report Number: 3005168196-2021-02415
• Device Sequence Number: 4774615
• Product Code: NRY
• UDI-Device Identifier: 00814548019802
• UDI-Public: 00814548019802
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K090752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2022
• 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: 07/23/2023
• Device Model Number: 5MAXJETDKIT
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F99078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 01/14/2005; 10/27/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 05/04/2022; 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005