MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER; NRY

Catalog Number	5MAXJET7KIT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the jet7 was kinked approximately 23.0, 24.0, 47.0, 112.0 and 116.5 cm from the hub.The jet7 was flushed while submerged and air was observed leaking from the catheter underneath the strain relief.The strain relief was unraveled and the jet7 was found to be punctured approximately 1.0 cm from the hub.During functional testing, the jet7 was able to advance through a demonstration neuron max with resistance due to the kinks and ovalization.Conclusions: evaluation of the returned jet7 revealed kinks along the catheter shaft.If the device is forcefully advanced against resistance, damage such as kinks may occur.The non-penumbra sheath identified in the complaint was not returned for evaluation; therefore, the root cause of the resistance could not be determined.Further evaluation revealed a puncture near the hub underneath the strain relief.This damage was likely incidental to the reported complaint.Penumbra coils 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.
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 jet 7 reperfusion catheter (jet7) from a penumbra system jet 7 kit.During the procedure, the physician experienced resistance during advancement of the jet7 through the non-penumbra sheath.The jet7 was unable to advance through the sheath, and therefore, was removed and no longer used in the procedure.The procedure was completed using another catheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9141616
• Report Number: 3005168196-2019-01843
• Device Sequence Number: 3123194
• Product Code: NRY
• UDI-Device Identifier: 00814548019918
• UDI-Public: 00814548019918
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173761
• 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): 09/04/2019
• 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: 11/08/2021
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F86966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• 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: 09/04/2019
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005