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

Catalog Number	3MAXC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
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 using penumbra system 3max reperfusion catheters (3maxcs).During the procedure, the physician noticed that a 3maxc was broken upon removal from the packaging.The 3maxc was then removed and the physician used another 3maxc to continue the procedure.While using the next 3maxc in the patient, the physician reported that it broke and was "sucked in by the penumbra vacuum".There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 3maxc was kinked approximately 8.0, 10.0, 25.0, 40.0, 55.0, 72.0, 117.5 and 124.0 cm from the hub.The device was stretched from approximately 125.5 ¿ 143.0 cm from the hub.The device was fractured approximately 143.0 cm from the hub.The total length of the returned device was approximately 143.0 cm.Conclusions: evaluation of the second returned 3maxc confirmed a fracture and revealed stretching on the distal end.If the device is forcefully retracted against resistance, damages such as these may occur.Based on the reported complaint, the root cause of the resistance could not be determined.The distal fractured segment was not returned for evaluation.Penumbra catheters 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.

• 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: 9235859
• Report Number: 3005168196-2019-01983
• Device Sequence Number: 13539513
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 09/25/2019
• 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: 04/04/2022
• Device Catalogue Number: 3MAXC
• Device Lot Number: F89403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 59
• Date Report Sent to FDA: 01/01/2005