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	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k)# that also applies to this complaint: (b)(4).Results: the jetd was kinked approximately 8.0, 73.0, 103.0, 119.0 cm from the hub.The jetd was ovalized approximately 18.0 thru 26.0 cm from the hub.During functional testing, a demonstration 3maxc was attempted to be advance through the returned jetd; however, resistance was encountered and the 3maxc could not be advanced any further.Conclusions: evaluation of the returned jetd confirmed that the catheter was ovalized.If the jetd is forcefully retracted through a closed or partially closed rotating hemostasis valve (rhv), damages such as ovalization may occur.Further evaluation of the returned jetd revealed kinks along the catheter shaft.These kinks were likely incidental to the reported complaint.The 3maxc identified in the complaint was not returned for evaluation.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the basilar and left vertebral arteries using a penumbra system jetd reperfusion catheter (jetd) from a penumbra system jetd kit.During the procedure, the physician successfully aspirated a part of the thrombus using the jetd and penumbra system 3max reperfusion catheter (3maxc).Upon removal of the jetd for flushing, the physician noticed that the proximal end was ovalized.The jetd was therefore removed and was no longer used in the procedure.The procedure was completed using another catheter and the same 3maxc.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: 9098905
• Report Number: 3005168196-2019-01792
• Device Sequence Number: 2623390
• Product Code: NRY
• UDI-Device Identifier: 00814548019802
• UDI-Public: 00814548019802
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 08/23/2019
• 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 Catalogue Number: 5MAXJETDKIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• 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: 08/23/2019
• Initial Report FDA Received Date: 09/20/2019
• 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