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

Model Number	5MAXJET7-B
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 jet 7 reperfusion catheter (jet7).During the procedure, the physician began aspirating with the jet7 to make the first pass and heard air leaking.Upon inspection of the jet7, the physician noticed that it was kinked and had a pin-size hole at the site of the kink.Therefore, the jet7 was removed.The procedure was completed using another jet7.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the jet7 was kinked approximately 2.5 cm and 58.0 cm from the hub.The strain relief was unraveled, and a hole was present at the proximal kink.Conclusions: evaluation of the returned jet7 confirmed a kink and a hole underneath the strain relief.If the jet7 is forcefully manipulated at extreme angles during use, damage such as this may occur.During functional testing, the jet7 was flushed with air while submerged, and bubbles were observed coming from the kinked location.Further evaluation of the returned jet7 revealed an additional kink in the catheter shaft.This kink was likely incidental to the reported complaint.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.

• 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: 9892241
• Report Number: 3005168196-2020-00460
• Device Sequence Number: 11288062
• Product Code: NRY
• UDI-Device Identifier: 00815948020955
• UDI-Public: 00815948020955
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K190010
• 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,Followup
• Report Date (Section B): 03/05/2020
• 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: 11/14/2022
• Device Model Number: 5MAXJET7-B
• Device Catalogue Number: 5MAXJET7
• Device Lot Number: F94267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005