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

Catalog Number	5MAXACE132
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
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 internal carotid artery (ica) using penumbra system ace 60 reperfusion catheters (ace60s).It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician advanced an ace60 through a neuron max 6f 088 long sheath (neuron max) to access the c6 segment of the target vessel; however, the physician experienced resistance, and the ace60 would not advance beyond the c1 segment.Therefore, the physician retracted the ace60 and steam-shaped the distal tip.Next, the physician put the ace60 in place for aspiration; however, no thrombus was being aspirated; therefore, the ace60 was retracted.Upon removal, the distal end of the ace60 was noticed to be broken.A second ace60 was opened, and the distal tip of the ace60 was steam-shaped.Next, the physician attempted another two passes in the target vessel using a stent retriever device, the ace60, and the same neuron max.However, no thrombus was being aspirated, and the vessel remained occluded.The physician decided not to attempt additional passes, and the procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned ace60 was kinked and the catheter lumen was damaged at approximately 132.0 cm from the hub.Conclusions: evaluation of the returned ace60 confirmed a distal kink and the catheter lumen was damaged at the kink.The reported distal tip steam shaping may have contributed to the kink and catheter lumen damage.This damage may have contributed to the inability to aspirate during the procedure.During functional testing, the ace60 was connected to a demonstration pump and tubing and was able to aspirate liquid.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.

• 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: 9208779
• Report Number: 3005168196-2019-01950
• Device Sequence Number: 10874630
• Product Code: NRY
• UDI-Device Identifier: 00814548017426
• UDI-Public: 00814548017426
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019
• 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: 07/02/2021
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F84489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005