MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE60 HI-FLOW KIT; NRY

Catalog Number	5MAXACE132KIT
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system ace 60 reperfusion catheter (ace60) was ovalized approximately 23.0, 59.0, and 103.0 cm from the hub.During functional analysis, a demonstration 3maxc was attempted to be advanced through the ace60.While advancing the 3maxc through the ace60, resistance was encountered as the 3maxc met the ovalization in the proximal shaft of the ace60 and the 3maxc could not be advanced any further.Conclusions: evaluation of the returned devices revealed that the 3maxc was fractured.Visual inspection of the fracture showed evidence of material deformation and stretching.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted against resistance, damage such as this may occur.Further evaluation of the returned device revealed that the 3maxc was kinked.This kink was likely incidental and may have occurred while packaging the device for return to penumbra.Evaluation of the returned devices revealed that the penumbra system ace 60 reperfusion catheter (ace60) was ovalized.This type of damage typically occurs due to improper handling during use.If the device is forcefully gripped or pinched during insertion, damage such as this may occur.The ovalization in the ace60 likely contributed to the fracturing of the 3maxc.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.This report is associated with mfr report number: 3005168196-2018-00528.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m3 segment of middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc) and a penumbra system ace 60 high-flow kit (kit).It was noted that the patient''s anatomy was not tortuous.During the procedure, the physician completed a pass using the penumbra system ace 60 reperfusion catheter (ace60) and the 3maxc.While removing the 3maxc from the ace60, the physician experienced resistance and upon removal of the 3maxc, the physician noticed that the end of the 3maxc was frayed and that the distal tip of the 3maxc was missing.The physician then decided to remove ace60.Upon removing and flushing the ace60 with saline, the missing piece of the 3maxc came out of the ace60 along with clot.The procedure was then successfully completed using a new ace60 and 3maxc.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE60 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7327900
• Report Number: 3005168196-2018-00529
• Device Sequence Number: 11160819
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 02/09/2018

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: Physician
• Device Expiration Date: 11/08/2020
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F80480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1