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

Catalog Number	5MAXACE064KIT
Medical Device Problem Codes	Break (1069); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-00733.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system ace 64 reperfusion catheter (ace64) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician experienced resistance while advancing the neuron max over a guidewire within the ica.It was reported that the patient¿s vessels were elongated and calcified.The physician then attempted to advance the ace64 and a penumbra system 3max reperfusion catheter (3maxc) over the guidewire within the neuron max.The 3maxc advanced with no issue; however, the physician experienced resistance while advancing the ace64, and the ace64 became stuck; therefore, the physician attempted to remove it.While retracting, the tip of the ace64 broke off within the patient.The physician then attempted to remove the tip of the ace64 using a snare device, however was unsuccessful.The tip of the ace64 was therefore left in the patient''s ica, and the neuron max and 3maxc were removed from the patient.Upon removal, the physician noticed that the neuron max was kinked approximately 20 centimeters proximal of the tip.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ace64 was stretched starting at its distal shaft transition approximately 105.0 cm from the hub.The ace64 was fractured approximately 127.0 cm from the hub.The ace64 was ovalized approximately 102.0 cm from the hub.Conclusions: evaluation of the returned neuron max revealed a kink on its distal shaft.This kink was likely a result of reported attempt to advance the device after it had been placed in the ica.The compliant reported the patient¿s vessels to be elongated and calcified.This anatomy likely contributed to the resistance experienced when advancing the neuron max.Evaluation of the returned ace64 revealed significant stretching and a fracture on its distal shaft.This damage was likely a result of forcefully retracting the device against resistance.This resistance may have been due to retracting the device through the kinked neuron max.Evaluation of the returned 3max revealed it was unable to be retracted from the ace64.There was no functional allegation against the 3max.It is likely the ace64 damage and stretching contributed to the inability to advance a mandrel through the 3max or remove it from the ace64 lumen.Evaluation of the returned non-penumbra devices revealed they were both significantly stretched on their distal shafts.These damages were also likely a cause of retraction through the severely kinked neuron max.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: 7412779
• Report Number: 3005168196-2018-00734
• Device Sequence Number: 1264107
• Product Code: NRY
• UDI-Device Identifier: 00814548016467
• UDI-Public: 00814548016467
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/13/2018

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: Physician
• Device Expiration Date: 08/14/2020
• Device Catalogue Number: 5MAXACE064KIT
• Device Lot Number: C03655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/22/2018
• 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: Required Intervention