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

Catalog Number	3MAXCKIT
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2019
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 m1 segment of the middle cerebral artery (mca) using a penumbra system 3max hi-flow kit.During the procedure, the physician advanced a stent retriever device through tortuous anatomy into the target vessel using a penumbra system 3max reperfusion catheter (3maxc) and a penumbra system jet 7 reperfusion catheter (jet 7).Upon removal of the 3maxc after placement of the stent retriever device, the physician noticed that the distal tip of the 3maxc had stretched and broken inside the jet 7.Therefore, the distal tip of the 3maxc was aspirated back into the canister.The procedure was completed using a new 3maxc and the same jet 7.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 3maxc stretching began approximately 125.0 cm from the hub.The 3maxc was fractured approximately 140.0 cm from the hub.The fractured distal segment was approximately 59.0 cm in length and the marker band was present.A slight ovalization was present on the distal end of the stretched device.The total length is 199.0 cm.Conclusions: evaluation of the returned 3maxc confirmed that the catheter shaft was stretched and fractured.If the device is forcefully retracted against resistance, damage such as stretching may occur.Subsequently, if the device is continued to be retracted while stretching, damage such as a fracture may result.An ovalization was present on the stretched segment of the distal fractured portion of the device.The ovalization may have contributed to the experienced resistance in tortuous anatomy.The non-penumbra stent retriever and jet7 identified in the complaint were not returned to penumbra for evaluation.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 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8417422
• Report Number: 3005168196-2019-00468
• Device Sequence Number: 1839885
• Product Code: NRY
• UDI-Device Identifier: 00814548019949
• UDI-Public: 00814548019949
• 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): 02/13/2019
• 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: 10/23/2021
• Device Catalogue Number: 3MAXCKIT
• Device Lot Number: F86643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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
• Date Report Sent to FDA: 01/01/2005