MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER; NRY

Model Number	PSC054KIT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-00825.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system 5max reperfusion catheter (5maxc), a penumbra system 3max reperfusion catheter (3maxc) and a neuron max 6f 088 long sheath (neuron max).It was noted that the patient¿s anatomy was mildly tortuous.During the procedure, the physician experienced slight resistance while advancing the 5maxc through the neuron max and while advancing the 3maxc through the 5maxc.After advancing the 3maxc into the distal branch of the target vessel, a pass was completed using a direct aspiration first pass technique (adapt).With the clot on the tip of the 3maxc and under aspiration, the physician retracted the 3maxc into the 5maxc with no significant resistance.However, it seemed like a section of the 3maxc broke off.After removing the 5maxc, it was noticed that approximately five to ten centimeters of the distal end of the 3maxc was found inside the 5maxc, along with the thrombus.The procedure was ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 5maxc was kinked at approximately 120.0 cm and 121.0 cm from the hub.Conclusions: evaluation of the returned 5maxc revealed kinks on its distal shaft.If the device is forcefully advanced against resistance, damage such as these may occur.During functional testing, a demonstration 3maxc was unable to advance through the kink on the 5maxc.Evaluation of the returned 3maxc confirmed a distal shaft fracture and revealed stretching and ovalizations on both sides of the fracture.This indicated that the device was stretched prior to fracture.If the device is forcefully retracted against resistance, damages such as these may occur.The kink on the returned 5maxc likely contributed to the resistance experienced in the procedure.Further evaluation of the 3maxc revealed kinks.These kinks may have occurred during advancement of the device against resistance.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 1.3005168196-2020-00825.

• Brand Name: PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10201401
• Report Number: 3005168196-2020-00826
• Device Sequence Number: 2234224
• Product Code: NRY
• UDI-Device Identifier: 00814548016771
• UDI-Public: 00814548016771
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020
• 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: 10/20/2022
• Device Model Number: PSC054KIT
• Device Catalogue Number: PSC054KIT
• Device Lot Number: F93772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005