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	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k)# that also applies to this complaint: k133317.Results: the jetd was kinked approximately 2.5, 11.0, 12.0, and 13.0 cm from the hub.The jetd was ovalized approximately 122.5 cm from the hub.Conclusions: evaluation of the returned jetd confirmed that the catheter was kinked.If the catheter is forcefully advanced against resistance or manipulated at extreme angles, damage such as a kink may occur.During the functional test, resistance was encountered as the kinks in the jetd entered the hub of the neuron max, and the jetd could not be advanced any further.Further evaluation of the returned jetd revealed an ovalization along the distal shaft.This damage was likely incidental to the reported complaint.The non-penumbra guide wire, the 3maxc, and the neuron max were not returned for evaluation.The kink in the jetd likely contributed to the inability to aspirate the clot experienced during the first pass of the procedure.Penumbra catheters 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 in the basilar artery using a penumbra system jet d kit.It was noted that the patient had a mid-basilar underlying stenosis with an adjacent basilar occlusion.During the procedure, while advancing the penumbra system jet d reperfusion catheter (jetd) with a penumbra system 3max reperfusion catheter (3maxc) and a guidewire through a neuron max 6f 088 long sheath (neuron max), the jetd appeared to kink; however, it was advanced to the clot and an aspiration pass was performed.It was noted that the clot was not completely removed after the first pass.Upon removal of the jetd after the first pass, it was noticed that the jetd appeared to have multiple kinks; therefore, it was not used for the remainder of the procedure.The procedure was successfully completed using the same neuron max, a penumbra system ace 68 reperfusion catheter (ace68), the same 3maxc, and a stent retriever device.There was no report of an adverse effect to the patient.

• 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: 9131339
• Report Number: 3005168196-2019-01831
• Device Sequence Number: 19398707
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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
• Report Date (Section B): 08/31/2019
• 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: 02/28/2022
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F88770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• 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: 08/31/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005