MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER; NRY

Model Number	5MAXACE064KIT
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
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 m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), penumbra system ace 64 reperfusion catheter (ace64), penumbra system 3max reperfusion catheter (3maxc), and neuron max 6f 088 long sheath (neuron max).It was reported the patient had fibromuscular dysplasia (fmd) and a tortuous anatomy.During the procedure, the clot was initially removed using the 3maxc, jet7, and neuron max, but the vessel re-clotted; therefore, the physician decided to use the same 3maxc and neuron max with the ace64 for a second treatment.While advancing the 3maxc and ace64 through the neuron max in the target vessel, the physician experienced resistance, and the tip of the ace64 "buckled" and perforated the carotid terminus; therefore, they were removed.Subsequently, a fistula was formed with the cavernous sinus.The physician then attempted to perform a vessel sacrifice but was unable to cross the lesion.To treat the vessel perforation, coils were placed in the cavernous sinus.The patient was stable at the end of the procedure, and the physician will re-attempt to perform a vessel sacrifice at a later date.
Additional Manufacturer Narrative
Potential adverse events in the labeling with the penumbra system include, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, vessel perforation, including death.Therefore, it was determined that the reported adverse event was an anticipated complication.Results: the ace64 has stress marks along the catheter shaft approximately 23.5 thru 28.0 cm from the hub.Conclusions: evaluation of the returned ace64 revealed stress marks along the catheter shaft.If the ace64 was advanced against resistance, damage such as stress marks may occur.During the functional test, a demonstration 3maxc was advanced through the returned ace64 and then through a demonstration neuron max without an issue.Therefore, the root cause of the reported resistance could not be determined.No other devices associated with the complaint were returned 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 ACE 64 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9521811
• Report Number: 3005168196-2019-02409
• Device Sequence Number: 595491
• Product Code: NRY
• UDI-Device Identifier: 00814548016467
• UDI-Public: 00814548016467
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 12/02/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2021
• Device Model Number: 5MAXACE064KIT
• Device Catalogue Number: 5MAXACE064KIT
• Device Lot Number: F82512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005