MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER; NRY

Model Number	5MAXJET7KIT
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system jet 7 reperfusion catheter (jet7) and a velocity.During the procedure, the jet7 was stretched upon removal.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system ace 60 reperfusion catheter (ace60), a velocity and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician completed one pass using the neuron max, ace60 and velocity.Upon removal of the ace60, the physician noticed that the distal end of the ace60 was stretched.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68) and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2020-00201.1.Section b.Box 5.Describe event or problem.2.Section d.Box 1.Brand name.3.Section d.Box 4.Lot #.4.Section d.Box 4.Expiration date.5.Section d.Box 4.Unique identifier.6.Section d.Box 4.Catalog #.7.Section g.Box 5.510(k) #.8.Section h.Box 4.Device manufacture date.Results: the ace60 was kinked approximately 3.5, 73.0, and 103.0 thru 104.5 cm from the hub.The ace60 was stretched approximately 106.0 thru 151.0 cm from the hub.Conclusions: evaluation of the returned ace60 confirmed that the catheter was stretched.If the ace60 is retracted against resistance, damage such as stretching may occur.During the functional test, resistance was encountered while attempting to advance the returned ace60 through a demonstration neuron max due to the stretched distal shaft, and the ace60 could not be advanced any further.Further evaluation of the returned ace60 revealed kinks along the catheter shaft.Some of these kinks may have occurred during use and some may be incidental to the reported complaint.Evaluation of the returned neuron max revealed a kink.The root cause of this damage could not be determined.However, the kink in the neuron max may have contributed to the stretched distal shaft of the ace60.During the functional test, resistance was encountered while attempting to advance a demonstration ace60 through the returned neuron max due to the kink, and the ace60 could not be advance any further.A jet7 device was not returned for evaluation.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 1.3005168196-2020-00943 h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9713200
• Report Number: 3005168196-2020-00201
• Device Sequence Number: 2401310
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• 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): 01/22/2020
• 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: 05/30/2022
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: C17889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005