MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Model Number	3MAXC-A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2019
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 middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc) and a penumbra system 3d revascularization device (psr3d).During the procedure, while advancing the psr3d through the 3maxc in the target vessel, the physician experienced resistance as the psr3d was halfway in the 3maxc; therefore, they were removed.The procedure was completed using the same psr3d and a non-penumbra catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 3maxc was kinked approximately 130.0 cm from the hub.Conclusions: evaluation of the returned 3maxc revealed a kink in the catheter shaft.If the 3maxc was forcefully advanced against resistance, damage such as a kink may occur.If the kinked 3maxc is advanced into the patient anatomy.The bends in the anatomy may completely close the catheter lumen where the kink is located.This damage may have contributed to the resistance experienced while advancing the psr3d through the 3maxc during the procedure.During the functional test, a demonstration psr3d and the returned psr3d were advanced through the returned kinked 3maxc without an issue.Evaluation of the returned psr3d revealed a functional device.The returned psr3d was advanced through the returned 3maxc without an issue.Further evaluation revealed a bend along the delivery wire.This bend was likely incidental to reported complaint.No other devices associated with the complaint were returned for evaluation.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra stents 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 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9617268
• Report Number: 3005168196-2020-00076
• Device Sequence Number: 11443514
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• 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): 12/30/2019
• 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: 09/30/2021
• Device Model Number: 3MAXC-A
• Device Catalogue Number: 3MAXC
• Device Lot Number: F86142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/01/2005