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

Model Number	PSC054L125-B
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2020
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 vertebral artery using a penumbra system 5max reperfusion catheter (5maxc), a neuron max 6f 088 long sheath (neuron max) and a non-penumbra balloon catheter.It was noted that the patient¿s vertebral vessels were elongated.During the procedure, the physician advanced a 5maxc through the neuron max.Then, while advancing the balloon catheter approximately 5 centimeters from the distal end of the 5maxc, the physician experienced resistance; therefore, the balloon catheter and 5maxc were removed.Upon removal, it was noticed that the balloon catheter and 5maxc were damaged.It was reported that 2 to 5 centimeters from the distal end of the 5maxc was damaged.The procedure was completed using a new 5maxc and new balloon catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 5maxc had multiple kinks from approximately 111.0 ¿ 116.0 cm from the hub.Conclusions: evaluation of the returned 5maxc revealed multiple kinks on the distal shaft.If the device is forcefully manipulated against resistance, damage such as kinks may occur.During functional testing, resistance was experienced while attempting to advance a demonstration catheter through the 5maxc due to the damage on the distal shaft, and the catheter could not advance any further.No other devices associated with the complaint were returned for evaluation; therefore, the root cause of resistance could not be determined.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.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9948530
• Report Number: 3005168196-2020-00542
• Device Sequence Number: 16926952
• Product Code: NRY
• UDI-Device Identifier: 00814548012759
• UDI-Public: 00814548012759
• 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): 03/17/2020
• 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: 04/21/2022
• Device Model Number: PSC054L125-B
• Device Catalogue Number: PSC054L125-B
• Device Lot Number: F89761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005